The Effect of Exercise on Ovarian Reserve

Open Study to Examine How Different Levels of Physical Activity Impact the Ovarian Reserve During the Pre-menopausal Period

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

Study Overview

• Status: Unknown
• Conditions: Physical Exercise
• Intervention / Treatment: Other: Physical exercise

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years	Other: Physical exercise; Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years will be recruited. These women will will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information. 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
Control group; Women who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Levels of anti-mullerian hormone	3 days after period
Number of Antral Follicle Count	3 days after period

Secondary Outcome Measures

Outcome Measure	Time Frame
Levels of Follicle-stimulating hormone	3 days after period
levels fo Luteinizing hormone	3 days after period
Levels of progesterone	3 days after period
Levels of estradiol	3 days after period
Levels of Thyroid-stimulating hormone	3 days after period
Levels of leptin	3 days after period
Menstrual duration	3 days after period
frequency of bleeding in every menstruation	3 days after period
amount of bleeding in every menstruation	3 days after period

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Yael Pasternak, MD, Meir Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• Duckitt K. Exercise during pregnancy. BMJ. 2011 Sep 15;343:d5710. doi: 10.1136/bmj.d5710. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• International Physical Activity Questionnaire

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 18, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 21, 2016
• Last Update Submitted That Met QC Criteria: December 18, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Meir Medical Center - Sport