Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2017-02-28
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
\-
20 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Meir Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yael Pasternak
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yael Pasternak, MD
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Helsinki Committee MMC
Role: CONTACT
Phone: 97297471588
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Meir Medical Center - Sport
Identifier Type: -
Identifier Source: org_study_id