The Effect of Exercise on Ovarian Reserve

Physical Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02999568
• Other study ID #: Meir Medical Center - Sport
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 18, 2016
• Start date: February 2017
• Est. completion date: August 2019

Study information

• Verified date: December 2016
• Source: Meir Medical Center
• Contact: Amir Wiser, MD
• Phone: 07297472901
• Email: Amir.Wiser[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Physical Exercise

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (10)

Clapp JF 3rd. Exercise during pregnancy. A clinical update. Clin Sports Med. 2000 Apr;19(2):273-86. Review. — View 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. — View Citation

Duckitt K. Exercise during pregnancy. BMJ. 2011 Sep 15;343:d5710. doi: 10.1136/bmj.d5710. — View 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. — View 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. — View Citation

Mâsse 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of anti-mullerian hormone		3 days after period	No
Primary	Number of Antral Follicle Count		3 days after period	No
Secondary	Levels of Follicle-stimulating hormone		3 days after period	No
Secondary	levels fo Luteinizing hormone		3 days after period	No
Secondary	Levels of progesterone		3 days after period	No
Secondary	Levels of estradiol		3 days after period	No
Secondary	Levels of Thyroid-stimulating hormone		3 days after period	No
Secondary	Levels of leptin		3 days after period	No
Secondary	Menstrual duration		3 days after period	No
Secondary	frequency of bleeding in every menstruation		3 days after period	No
Secondary	amount of bleeding in every menstruation		3 days after period	No

External Links

•   International Physical Activity Questionnaire