Running Head: FEMALE HORMONES AND ACL INJURY RATES Female Hormones and Their Effects on the Anterior Cruciate Ligament Injury Rate Increase Dylan M. Pavka University of North Georgia Contemporary Issues/Concerns in HPE – KINS 7700 23 February 2022 1 FEMALE HORMONES AND ACL INJURY RATES 2 Female Hormones and Their Effects on the Anterior Cruciate Ligament Injury Rate Increase Abstract Women are tearing their anterior cruciate ligament at a significantly higher rate than their male counterparts. This study looks at the different stages of the menstrual period and how it may affect the rates at which these injuries occur. This study took all female athletes in the school district who sustain anterior cruciate ligament injuries and determine which stage of menstruation they are in. This allows for the experimenter to divide the subjects into groups to determine significance. Overall, the increased rates in the follicular phase and menstruation are significantly higher than that of ovulation and the luteal phase. This is not what was expected from my hypothesis. Introduction Background of Study While working as an Athletic Trainer working with various sports, anterior cruciate ligament (ACL) injuries tend to be the most common season-ending injury. While many people may not know precisely where the ACL is, they understand that their season is over if torn. While working with women's athletics, this is generally more concerning. Many studies show that a woman has a higher rate of ACL injury. At the same time, they are undergoing a literature review focusing on the hormones and their effects on female ligament laxity. While there are many anatomical differences between women and men, such as higher Q angles, and a shallow femoral notch, there still could be various other risk factors predetermining a woman to a higher ACL injury rate. Women are already at an increased risk of injury with these anatomical predispositions. Throughout a woman's menstrual cycle, the levels of different hormones change. FEMALE HORMONES AND ACL INJURY RATES 3 There have been correlations between certain menstrual cycle stages that increase the laxity of ligaments in the female body. According to a study performed by Heitz, Eisenman, Beck, and Walker (1999), progesterone and estrogen levels are significantly elevated in the menstrual cycle stages where the ACL has higher laxity. Since there is already an increase in injury due to anatomical differences, an increase in laxity in the ACL could be the deficiency causing the injuries. Hypotheses Hypothesis An increase in injury rate will positively correlate with the participant being in the luteal phase and ovulation. Null Hypothesis There will be no correlation between injury rates and stages of the menstrual cycle. Assumptions Assumptions throughout the experiment are that all women will have the same fluctuation of hormones in the different stages of the menstrual cycle, and injuries will be noncontact in nature. Limitations Possible limitations proposed are the limited sample size. For example, while ACL injuries are common in females, a particular school district could only have a small number of female ACL injuries. Another limitation would be parents not allowing their children to participate in this study. Delimitations FEMALE HORMONES AND ACL INJURY RATES 4 Delimitations have multiple Athletic Trainers at various schools reporting ACL ligament injuries increasing the ACL injury exposure. Definition of Key Terms ACL Injury: An injury to the anterior cruciate ligament sprain varying from grade one to three. Estrogen: a hormone found mainly in women responsible for sexual and reproductive development Progesterone: a hormone released by the female body stimulating the uterus to prepare for pregnancy Relaxin: a hormone produced by the female body that affects the reproductive system and pregnancy. Review of Literature Physiology of the Menstrual Cycle It is a commonly known fact women menstruate. Menstruation is a continuous cycle with a median duration of 28-days (Reed and Carr, 2018). This cycle is natural in women as the body prepares itself for reproduction. The menstrual cycle can be broken down into four stages: menstruation, the follicular phase, ovulation, and the luteal phase (Reed and Carr, 2018; Thiyagarajan, Basit, Jeanmonod, 2020). During this time, the hormone levels of various types of hormones fluctuate. Hormones fluctuate to control the menstrual cycle (Thiyagarajan, Basit, Jeanmonod, 2020). Menstrual cycle hormone secretion begins at puberty. Puberty for women starts at an age range of 10 to 16. During this time, a woman’s hypothalamus will begin secreting gonadotropinreleasing hormone (GnRH) (Thiyagarajan, Basit, Jeanmonod, 2020). This hormone activates the FEMALE HORMONES AND ACL INJURY RATES 5 anterior pituitary gland to release follicle hormone (FSH) and luteinizing hormone (LH). These two hormones are released into the circulatory system and transported to the receptors located in the ovaries. In addition, LH stimulates the ovaries to release progesterone and androstenedione. Androstenedione, when diffused, will be converted to testosterone. Once progesterone levels increase in the bloodstream, it will cause the anterior pituitary gland to stop releasing FSH and LH (Thiyagarajan, Basit, Jeanmonod, 2020). The follicular phase is the beginning of the menstrual cycle. During this phase, the endometrial layer of the uterus increases, and the follicle matures to release the oocyte (Thiyagarajan, Basit, Jeanmonod, 2020; Reed and Carr, 2018). This stage has an average duration of zero to 14 days. However, this is the stage of the menstrual cycle causing the most variation between women. The increase in estrogen levels in this phase causes an increase in the secretion of FSH from the pituitary gland (Thiyagarajan, Basit, Jeanmonod, 2020). The secretion of FSH causes folliculogenesis (Reed and Carr, 2018). However, at the end of the follicular phase, the high levels of estrogen in the circulatory system cause the release of FSH to slow (Thiyagarajan, Basit, Jeanmonod, 2020). Ovulation is the stage of the menstrual cycle where the oocyte is released from the ovary. During ovulation, the levels of FSH and LH are at a high level (Thiyagarajan, Basit, Jeanmonod, 2020). The release of the oocyte is stimulated due to the peak level of LH, also known as the LH surge. This LH surge is also causing the stimulation of progesterone synthesis (Reed and Carr, 2018). These high levels of FSH and LH cause the oocyte to be released from its follicle and prepare the cervix for potential sperm (Thiyagarajan, Basit, Jeanmonod, 2020). During the luteal phase, the body uses the high LH levels from ovulation to stimulate the release of progesterone. The luteal stage is most commonly 14-days long. Progesterone is the FEMALE HORMONES AND ACL INJURY RATES 6 dominant hormone in the luteal phase (Reed and Carr, 2018; Thiyagarajan, Basit, Jeanmonod, 2020). The corpus luteum and the endometrium are prepared for a fertilized ovum during this phase. If a fertilized ovum is successfully implanted in the endometrium, progesterone and estrogen levels will remain at their high levels (Thiyagarajan, Basit, Jeanmonod, 2020). The progesterone levels in this phase slow endometrial proliferation. However, without the implantation of a fertilized ovum, the progesterone levels drop at the end of the luteal phase and cause a thickening of the cervix (Thiyagarajan, Basit, Jeanmonod, 2020). Menstruation begins when the pregnancy is not present. During normal menstruation, FSH, LH, progesterone, and estrogen all decrease and cause menses. Menses is when the endometrial lining releases the stored blood in the tissue (Thiyagarajan, Basit, Jeanmonod, 2020). When the levels of progesterone constrict, the arteries surround the endometrium. This constriction of the arteries causes the superficial endometrial layer (Reed and Carr, 2018). Increased Rate of Injury With the increase in women’s participation in athletics throughout history, an increased rate of ACL injury has been noticed. ACL injuries have shown a decline in athletic ability after the injury (Tramer et al., 2020). When the athletic ability is affected by an injury, there needed to be preventative measures done to prevent damage. Even with reconstructive surgery, an ACL injury can cause significant changes in the biomechanics of the knee due to increased laxity (L’Hermette et al., 2018). The population primarily affected by these increased rates is 14-21 years of age (Csintalan, Inacio, Funahashi, 2008). There have been many studies done to highlight this increased rate among women. There has yet to be a single difference between men and women correlated with this increased rate. It has been found in various sports to have an increased rate compared to their male counterparts. In one study published in the Orthopedic FEMALE HORMONES AND ACL INJURY RATES 7 Journal of Sports Medicine, functional knee braces help lower the risk of injury with proper use (Perrone et al., 2019). There are many reasons a woman is predetermined based on the anatomy and physiology of the human body. One of these is the hormonal differences. A woman’s hormone levels constantly change with the menstrual cycle (Wojtys et al., 1998; Yu, Stephen, Hatch, Panossian, Finerman, 1999; Heitz et al., 1999; Slauterbeck, Fuzie, Smith, Clark, Xu, Starch, Hardy, 2002; Lephart et al. 2002; Ireland, 2005, 2016). Another is the broader pelvis in women. The broader hips will cause an increase in the Q-angle found in women. Women, on average, have a Q-angle of 15 degrees. This is significantly more than the male average of 11.3 degrees (Mitani, 2017). With this broader Q-angle, the knee is placed in a valgus state (Hewett et al., 2006; Kizilgoz et al., 2017). Hormones and Laxity in Ligaments in Women Many studies highlight the differences in the laxity of ligaments between men and women. A significant difference between men and women is the hormone levels throughout the body. Ligaments throughout the body are affected by the constant hormone changes throughout the menstrual cycle. Studies have been done correlating the laxity of the ACL and an increase in estrogen during the menstrual cycle (Liu et al., 1997; Heitz et al., 1999). In addition, there have been studies that have had positive correlations between the luteal phase and ovulation and an increase in ACL injury (Huston et al., 2000; Deie et al., 2002; Adachi, Nawata, Maeta, Kurozawa, 2007). During this study, they did not look at the changing relaxin levels. Relaxin is a hormone detectable in the mid-luteal phase into ovulation and throughout pregnancy (Loumaye, Depreester, Donnez, and Thomas, 1984; Johnson, Carter, Lightman, 1993; Heitz et al., 1999; Bathgate, Hsueh, Sherwood, 2006; Ireland, 2016). The highest levels of FEMALE HORMONES AND ACL INJURY RATES 8 relaxin are during pregnancy and are essential in the dilation of the cervix and laxity in the pubic symphysis. Its non-reproductive purposes are promoting wound healing, protecting the cardiac tissue, and as an antifibrotic agent (Bathgate, Hsueh, Sherwood, 2006). The corpus luteum produces relaxin during the menstrual cycle (Seneviratne et al., 2004; Yoshino et al., 2020). According to toa study published in the Public Library of Science in 2016, there has been a positive correlation between relaxin peptide levels in the blood and ACL injury (Dehghan et al., 2016). The relaxin reduces the collagen presence in the ligament and tendons during peak levels. (Mojtys, Huston, Lindenfeld, Hewett, Greenfield, 1998, Pearson, Burgess, Onambele, 2011). Relaxin has a positive correlation between patellar tendon stiffness and relaxin levels in the blood. This indicates that relaxin affects the integrity of tendons and ligaments during menstruation. Hormonal supplementations have shown a correlation between use and ACL injury rates (Deie et al., 2002). Methodology Introduction After an injury is suspected and confirmed, the researcher will conduct in-person interviews to evaluate the stage of menstruation at the time of injury. The process will consist of various questions to determine the average length of the menstrual cycle and when their last menstruation. When analyzing the participants given to the interviewer, the interviewer will group each participant based on the stage of menstruation the interviewer believes they are in based on the answers to the interview questions. Participants FEMALE HORMONES AND ACL INJURY RATES 9 This study will consist of female high school athletes aged 13-18. All participants will be from the same school district. The participants will be participating in sports at the time of injury. There is no limit on whether the participant has a history of injury. All willing anterior cruciate ligament injury athletes will be selected for this study. Each participant will be asked if they are willing and able to participate and have the right to choose to decline. This will be a qualitative study. Qualitative studies rely on inductive reasoning processes to interpret and structure the data collected. Ethical Considerations Children are not the legal age for consent to treatments or procedures involved in research under the law of the study’s jurisdiction. Generally, the law considers any person under 18 years old to be a child. Each subject has the right to anonymity and safety and ends their participation at any point. All willing participants and their legal guardians must complete a detailed consent form. It is critical that the legal guardians and all participants understand their rights and consent to participation (Department of Human Research Protections). The only identifying factors of the participants included during the study will be the sports they participate in, the mechanism of injury, their age, and their stage of menstruation. The participants will have the right to end participation in this study at any point. Since all participants are considered minors, the legal guardian will be notified and given a consent form for participation. The participant will be promptly removed from the study, and data will be removed from the study. All notes taken during interviews will go into a file, and the file will be placed in a secured file cabinet. The researcher will be the only individual with access to the cabinet. This study will require Institutional Review Board (IRB) approval before commencing. Materials FEMALE HORMONES AND ACL INJURY RATES 10 The participants will be diagnosed by a medical professional. Since the participants have suffered an injury, their parents must be notified accordingly. During this time, verbal consent will be initiated, and written approval will follow. Since the participants will be interviewed, they will not need any materials. However, the researcher will write the information from each interview down on paper. All information collected will be secured in a locked filing cabinet. The researcher will be the only individual with access to the cabinet. Experimental Design The participants will report to their Athletic Trainer for injury evaluation immediately after the injury occurs. Once a diagnosis has been made and an injury to the subject's anterior cruciate ligament is determined, the researcher will be notified. The researcher will call the diagnosing athletic trainer to complete the proceedings. This interview will consist of questions regarding menstrual history, current participation status, and mechanism of injury. The athletes will be instructed to report back to the athletic trainer at the start of their next menstruation. Data Analysis Each participant will be placed into one of four groups based on their responses during the interview. If it has been determined that a participant was in the follicular phase, they will be in group 1. If it has been determined that a participant was in ovulation, they will be in group 2. If it has been determined that a participant was in the luteal phase, they will be in group 3. Finally, if it has been determined that a participant was menstruating, they will be in group 4. When all the interviews are completed, an analysis of the responses in each group will be conducted. This will help determine if the injury rate is significant within different menstrual cycle stages. After the grouping of each participant, a chi-square is indicated to assess the data. FEMALE HORMONES AND ACL INJURY RATES 11 Using a Chi-Square will determine if there is an association between the groups. This test will also check whether the sample is distributed with a specific theoretical distribution. A chi-square will test the study’s validity and assure credibility (Morrow et al., 2016). Results After the injury had occurred, the anterior cruciate ligament subjects were interviewed to determine their stage of menstruation at the time of injury. These young women ages 13-18 years old are injuring their anterior cruciate ligament significantly more during the follicular phase and menstruation, collectively making up 79% of the sample (Follicular Phase 11/28, Menstruation 11/28, P=0.05) (Table 1). Table 1. The number of injured participate in each stage of their menstrual cycle. Stages of Menstruation Follicular Phase Ovulation Luteal Phase Menstruation P-Value Note: P-value from Chi-Square is presented. Number of Subjects Injured 11 2 4 11 0.05 Injuries during ovulation made up 7% of the sample, and 14% were in their luteal phase (Table 1). The criteria to determine their stage of menstruation was to use the date of their current or subsequent period. Discussion This data is mock data and has data made up by the author. None of the subjects are real people, as approval from the institution’s IRB board was not sought. The application was submitted but was withdrawn due to semester and resource constraints. The experience was FEMALE HORMONES AND ACL INJURY RATES 12 gained from the application process on protecting human rights, privacy, and safety during the application period. Previous studies have investigated various reasons why there are increased rates of women injuring their anterior cruciate ligament in women’s sports. The search for data still occurs. There are things being done to lower this risk, but there are very few studies with excellent data to support a definitive reason for the increased rate of injury. However, few studies have been done with human subjects to report hormones effects on these injury rates. They often look at the laxity of the anterior cruciate ligament and not the injury rates themselves. Therefore, this study attempted to see the difference in the different stages of the menstrual cycle and their effects on the rate of an injury during these stages. In terms of data, many participants injured their anterior cruciate ligament during the follicular phase and menstruation. The results of this study agree with previous studies that look at the laxity of the anterior cruciate ligament during the menstrual period (Liu et al., 1997; Heitz et al., 1999). There are significantly more injuries during the follicular and menstruation than during ovulation and luteal phases. However, this disagrees with some previous studies on the degree to which laxity plays a role in increasing injury rate (Huston et al., 2000; Deie et al., 2002; Adachi, Nawata Maeta, Kurozawa, 2007). The current investigation shows significantly fewer participants had injuries during the luteal phase and menstruation. This would also disagree with the hypothesis, which was based on the relaxin levels in the body during this time. The data shows the opposite, with increased injury rates when relaxin levels are lower. In conclusion, this investigation looked at an ACL injury with a limited sample size for a short time. The study was also limited by not testing hormone levels in the blood to determine FEMALE HORMONES AND ACL INJURY RATES 13 the stage of menstruation. This data could have brought more accuracy to the data. However, significantly more ACL injuries occur during the follicular phase and menstruation than during ovulation and the luteal phase. There was statistical significance in the differences between the rates of damage during the follicular phase and menstruation than ovulation and luteal phase. Conclusion The literature advocates for an association between an increased injury rate to the anterior cruciate ligament during the luteal phase and ovulation. Ovulation and the luteal phase have been shown to have traceable relaxin levels throughout the body. However, many studies are looking at the evidence of increased laxity in different menstrual cycle stages and not at the increased rates of injury during individual stages. There is more data to be collected on this topic. Women are tearing their anterior cruciate ligament at increased rates than their male counterparts. This is detrimental to their sports performance and mental health. There needs to be data which can be applied to prevent these catastrophic injuries. FEMALE HORMONES AND ACL INJURY RATES 14 References Adachi, N., Nawata, K., Maeta, M., & Kurozawa, Y. (2007). Relationship of the menstrual cycle phase to anterior cruciate ligament injuries in teenaged female athletes. Archives of Orthopaedic and Trauma Surgery, 128(5), 473–478. Bathgate, R., Hsueh, A., David-Sherwood, O. (2006). Physiology and molecular biology of the relaxin peptide family. Knobil and Neill's Physiology of Reproduction, 679–768. Csintalan, R. P., Inacio, M. C., & Funahashi, T. T. (2008). The incidence rate of anterior cruciate ligament reconstructions. The Permanente journal, 12(3), 17–21.At the same time, Dehghan, F., Soori, R., Dehghan, P., Gholami, K., Muniandy, S., Azarbayjani, M. A., & Yusof, A. (2016). In rodents, knee laxity and relaxin receptor isoforms expression (RXFP1/RXFP2) in the knee throughout the phases of the estrous cycle. PLOS ONE, 11(8). Deie, M., Sakamaki, Y., Sumen, Y., Urabe, Y., & Ikuta, Y. (2002). Anterior knee laxity in young women varies with their menstrual cycle. International Orthopaedics, 26(3), 154–156. Gale, N. K., Heath, G., Cameron, E., Rashid, S., & Redwood, S. (2013). Using the framework method for analyzing qualitative data in multi-disciplinary health research. BMC Medical Research Methodology, 13(1). Grossoehme, D. H. (2014). Overview of qualitative research. Journal of health care chaplaincy. FEMALE HORMONES AND ACL INJURY RATES 15 Ireland, M. (2016). The female ACL: Why is it more prone to injury? Journal of Orthopaedics, 13(2). https://doi.org/10.1016/s0972-978x(16)00023-4 Ireland, M. L. (2005). The female athlete. Current Sports Medicine Reports, 4(2), 57–60. Heitz, N. A., Eisenman, P. A., Beck C. L., Walker, J. A (1999). Hormonal changes throughout the menstrual cycle and increased anterior cruciate ligament laxity in females. Journal of athletic training. Hewett, T. E., Myer, G. D., & Ford, K. R. (2006). Anterior cruciate ligament injuries in female athletes: Part 1, mechanisms and risk factors. The American journal of sports medicine, 34(2), 299–311. Huston, L. J., Greenfield, M. L., & Wojtys, E. M. (2000). Anterior cruciate ligament injuries in the female athlete. Potential risk factors. Clinical Orthopedics and related research, (372), 50–63. Johnson, M. R., Carter, G., Grint, C., & Lightman, S. L. (1993). Relationship between ovarian steroids, gonadotrophins, and relaxin during the menstrual cycle. Acta Endocrinologica, 129(2), 121–125. Kızılgöz, V., Sivrioğlu, A. K., Ulusoy, G. R., Aydın, H., Karayol, S. S., & Menderes, U. (2018). Analysis of the risk factors for Anterior Cruciate Ligament Injury: Investigating structural tendencies. Clinical Imaging, 50, 20–30. FEMALE HORMONES AND ACL INJURY RATES 16 Lephart, S. M., Ferris, C. M., & Fu, F. H. (2002). Risk factors associated with noncontact anterior cruciate ligament injuries in female athletes. Instructional course lectures, 51, 307–310. Liu, S. H., Al-Shaikh, R. A., Panossian, V., Finerman, G. A., & Lane, J. M. (1997). Estrogen affects the cellular metabolism of the anterior cruciate ligament. A potential explanation for female athletic injury. The American journal of sports medicine, 25(5), 704–709. Loumaye, E., Depreester, S., Donnez, J., & Thomas, K. (1984). Immunoreactive relaxin surge in the peritoneal fluid of women during the Midluteal phase**supported by grant 3 4450 83 from the Fonds de la Recherche Scientifique Medicale Belgium. Fertility and Sterility, 42(6), 856–860. L’Hermette, M., Coquart, J., Senioris, A., Chamari, K., Tourny, C., & Dujardin, F. (2018). Pathological knee laxity in Elite Women Team Handball Players: A pilotstudy. Biology of Sport, 35(2), 159–164. Mitani, Y. (2017). Gender-related differences in lower limb alignment, range of joint motion, and the incidence of sports injuries in Japanese university athletes. Journal of Physical Therapy Science, 29(1), 12–15. Morrow, J. R., Mood, D., Disch, J. G., & Kang, M. (2016). Measurement and evaluation in human performance. Human Kinetics. Office for Human Research Protections (OHRP). (2021, December 6). Office for Human Research Protections. HHS.gov. FEMALE HORMONES AND ACL INJURY RATES 17 Perrone, G. S., Webster, K. E., Imbriaco, C., Portilla, G. M., Vairagade, A., Murray, M. M., & Kiapour, A. M. (2019). Risk of secondary ACL injury in adolescents prescribed functional bracing after ACL reconstruction. Orthopaedic Journal of Sports Medicine, 7(11), 232596711987988 Reed, B.G., Carr, B.R. (2018). The average menstrual cycle and the control of ovulation. National Center for Biotechnology Information. Seneviratne, A., Attia, E., Williams, R. J., Rodeo, S. A., & Hannafin, J. A. (2004). The effect of estrogen on ovine anterior cruciate ligament fibroblasts: cell proliferation and collagen synthesis. The American journal of sports medicine, 32(7), 1613–1618. Thiyagarajan, D.K., Basit, H., Jeanmonod, R (2020). Physiology, menstrual cycle. National Center for Biotechnology Information. Slauterbeck, J. R., Pankratz, K., Xu, K. T., Bozeman, S. C., & Hardy, D. M. (2004). Canine ovariohysterectomy and orchiectomy increase the prevalence of ACL Injury. Clinical Orthopaedics and Related Research, 429, 301–305. Tramer, J. S., Khalil, L. S., Ziedas, A., Mehran, N., & Okoroha, K. R. (2020). After anterior cruciate ligament reconstruction, return to play and performance in the Women’s National Basketball Association. Orthopaedic Journal of Sports Medicine, 8(9), 232596712094707. Wojtys, E. M., Huston, L. J., Lindenfeld, T. N., Hewett, T. E., & Greenfield, M. L. (1998). Association between the menstrual cycle and anterior cruciate ligament injuries in female athletes. The American Journal of Sports Medicine, 26(5), 614–619. FEMALE HORMONES AND ACL INJURY RATES 18 Yoshino, O., Ono, Y., Honda, M., Hattori, K., Sato, E., Hiraoka, T., Ito, M., Kobayashi, M., Arai, K., Katayama, H., Tsuchida, H., Yamada-Nomoto, K., Iwahata, S., Fukushi, Y., Wada, S., Iwase, H., Koga, K., Osuga, Y., Iwaoka, M., & Unno, N. (2020). Relaxin-2 may suppress endometriosis by reducing fibrosis, scar formation, and inflammation. Biomedicines, 8(11), 467. Yu, W. D., Liu, S. H., Hatch, J. D., Panossian, V., & Finerman, G. A. (1999). Effect of estrogen on cellular metabolism of the human anterior cruciate ligament. Clinical Orthopaedics and Related Research, 366, 229–238. FEMALE HORMONES AND ACL INJURY RATES 19 Female Hormones and Their Effects on the Anterior Cruciate Ligament Injury Rate Increase Questionnaire 1. What is your age? ____ If not between the ages of 13-18 years old, stop the questionnaire now. 2. Have you sustained an injury to your anterior cruciate ligament that a medical professional has diagnosed? a. Yes b. No 3. What was the date of your injury? _________________ 4. What was the start date of your last period? _______________ 5. End of your last period? __________________________ 6. If recent, are you still menstruating? a. Yes b. No 7. Are you willing to report your next period to your Athletic Trainer? a. Yes b. No Completed by Interviewer Date of next period __________________________ Stage of the menstrual cycle. 1. Follicular Phase 3. Ovulation 2. Luteal Phase 4. Menstruation FEMALE HORMONES AND ACL INJURY RATES Research Informed Consent TITLE OF STUDY Which of the following is true regarding the U.S. Federal Research Misconduct Policy? ______________________________________________________________________ PRIMARY RESEARCHER Name - __Dylan Pavka_____________________ Department – _Sports Medicine______________________ Address – _210 Sports Dr._________ City _Big Rapids_____ State _Michigan_______ Phone - __ (989)494-8594_____________________ Email – _dmpavk5908@ung.edu______________________ PURPOSE OF STUDY To bring evidence towards hormones roles in ACL injury to help prevent future injury ______________________________________________________________________ ______________________________________________________________________ PROCEDURES The processes will consist of various questions to determine the average length of the ______________________________________________________________________ menstrual cycle and when their last menstruation. The answers to the interview will be ______________________________________________________________________ analyzed, and chosen groups associated with the stage of the menstrual cycle the ______________________________________________________________________ individual is in at the time of injury. ______________________________________________________________________ RISKS There are no inherent physical or mental risks associated with this study. ______________________________________________________________________ ______________________________________________________________________ 20 FEMALE HORMONES AND ACL INJURY RATES 21 BENEFITS Help with preventing future female athletes form injuring their ACL. ______________________________________________________________________ ______________________________________________________________________ CONFIDENTIALITY Please do not write any identifying information. Every effort will be made by the researcher to preserve your confidentiality including the following: Assigning code names/numbers for participants that will be used on all research notes and documents Keeping notes, interview transcriptions, and any other identifying participant information in a locked file cabinet in the personal possession of the researcher. Participant data will be kept confidential except in cases where the researcher is legally obligated to report specific incidents. These incidents include, but may not be limited to, incidents of abuse and suicide risk. CONTACT INFORMATION If you have questions at any time about this study, or you experience adverse effects as the result of participating in this study, you may contact the researcher whose contact information is provided on the first page. If you have questions regarding your rights as a research participant, or if problems arise which you do not feel you can discuss with the Primary Researcher directly by telephone at _______________________ or at the following email address _______________________. VOLUNTARY PARTICIPATION Your participation in this study is voluntary. It is up to you to decide whether or not to take part in this study. If you decide to take part in this study, you will be asked to sign a consent form. After you sign the consent form, you are still free to withdraw at any time and without giving a reason. Withdrawing from this study will not affect the relationship you have, if any, with the researcher. If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed. Note: Please delineate the "Consent" section of the Informed Consent Form by drawing a line across the page (like this - Example). This delineation is important because the consent form grammar shifts from second person to first person, as shown in the example. FEMALE HORMONES AND ACL INJURY RATES CONSENT I have read and I understand the information provided and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I voluntarily agree to take part in this study. Participant’s Guardian #1 Signature_________________________Date_______ Participant’s Guardian #2 Signature_________________________Date_______ Participant's Signature _____________________________ Date __________ Researcher’s Signature ____________________________ Date __________ 22