Clinical trial NCT02999568: The Effect of Exercise on Ovarian Reserve
Official title: Open Study to Examine How Different Levels of Physical Activity Impact the Ovarian Reserve During the Pre-menopausal Period
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physical Exercise
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control group - Recruitment will be done through Gynocologis tEmergency Experimental group - Recruitment will be done through sport centers

Brief summary: The purpose of this study is to examine how different levels of physical activity impact the ovarian reserve during the pre-menopausal period

Detailed description: Two groups are included:

1. The study group: women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years
2. The control group: women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire , for the past 3 years

Women who meet the criteria for inclusion for will be recruited to the study after signing a consent form. Recruitment will be done through sport centers. The control group will include women being examined in gynecologic emergency department, after signing a consent form, if they meet the control group's inclusion criteria. These women will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information (see below). Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow.

Data collection:

1. Demographic information on age, weight, height, BMI, marital status
2. Medical information regarding chronic diseases and medications
3. Obstetrical history
4. Information regarding physical activities in the version of International Physical Activity Questionnaire .
5. Information about menstrual behavior: irregularity (yes/no) frequency (less than 21 days between 21-35 days, over 35 days), menstrual duration (less than 3 days 3-7 days, or over 7 days) bleeding amount according to the number of pads per day (up to 1, 2, 4 or 5 pads).
6. Hormonal profile - Follicle-stimulating hormone , Luteinizing hormone , progesterone, Estradiol, Thyroid-stimulating hormone .
7. Antral Follicle Count, Anti-mullerian hormone
8. Leptin levels -reflecting metabolic changes.

Eligibility criteria: Inclusion Criteria:

Study group:

1. Women between 20-35 years of age who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
2. BMI 18-25
3. Regular menstruation

Control group:

1. Women between 20-35 years of age who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
2. BMI 18-25
3. Regular menstruation

Exclusion Criteria:

1. Polycystic ovary syndrome 2. Endometriosis 3. Diabetes 4. Hyper/hypothyroidism 5. BMI\>25, BMI\<18 6. Active or past eating disorder

-

Primary outcomes:
measure: Levels of anti-mullerian hormone
timeFrame: 3 days after period
measure: Number of Antral Follicle Count
timeFrame: 3 days after period
Secondary outcomes:
measure: Levels of Follicle-stimulating hormone
timeFrame: 3 days after period
measure: levels fo Luteinizing hormone
timeFrame: 3 days after period
measure: Levels of progesterone
timeFrame: 3 days after period
measure: Levels of estradiol
timeFrame: 3 days after period
measure: Levels of Thyroid-stimulating hormone
timeFrame: 3 days after period
measure: Levels of leptin
timeFrame: 3 days after period
measure: Menstrual duration
timeFrame: 3 days after period
measure: frequency of bleeding in every menstruation
timeFrame: 3 days after period
measure: amount of bleeding in every menstruation
timeFrame: 3 days after period
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Yael Pasternak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. doi: 10.1001/jama.273.5.402.
citation: Clapp JF 3rd. Exercise during pregnancy. A clinical update. Clin Sports Med. 2000 Apr;19(2):273-86. doi: 10.1016/s0278-5919(05)70203-9.
citation: Duckitt K. Exercise during pregnancy. BMJ. 2011 Sep 15;343:d5710. doi: 10.1136/bmj.d5710. No abstract available.
citation: Rich-Edwards JW, Spiegelman D, Garland M, Hertzmark E, Hunter DJ, Colditz GA, Willett WC, Wand H, Manson JE. Physical activity, body mass index, and ovulatory disorder infertility. Epidemiology. 2002 Mar;13(2):184-90. doi: 10.1097/00001648-200203000-00013.
citation: Oosthuyse T, Bosch AN. The effect of the menstrual cycle on exercise metabolism: implications for exercise performance in eumenorrhoeic women. Sports Med. 2010 Mar 1;40(3):207-27. doi: 10.2165/11317090-000000000-00000.
citation: Clark AM, Ledger W, Galletly C, Tomlinson L, Blaney F, Wang X, Norman RJ. Weight loss results in significant improvement in pregnancy and ovulation rates in anovulatory obese women. Hum Reprod. 1995 Oct;10(10):2705-12. doi: 10.1093/oxfordjournals.humrep.a135772.
citation: Hollmann M, Runnebaum B, Gerhard I. Effects of weight loss on the hormonal profile in obese, infertile women. Hum Reprod. 1996 Sep;11(9):1884-91. doi: 10.1093/oxfordjournals.humrep.a019512.
citation: Morris SN, Missmer SA, Cramer DW, Powers RD, McShane PM, Hornstein MD. Effects of lifetime exercise on the outcome of in vitro fertilization. Obstet Gynecol. 2006 Oct;108(4):938-45. doi: 10.1097/01.AOG.0000235704.45652.0b.
citation: Evenson KR, Calhoun KC, Herring AH, Pritchard D, Wen F, Steiner AZ. Association of physical activity in the past year and immediately after in vitro fertilization on pregnancy. Fertil Steril. 2014 Apr;101(4):1047-1054.e5. doi: 10.1016/j.fertnstert.2013.12.041. Epub 2014 Feb 10.
citation: Masse LC, de Niet JE. Sources of validity evidence needed with self-report measures of physical activity. J Phys Act Health. 2012 Jan;9 Suppl 1:S44-55. doi: 10.1123/jpah.9.s1.s44.