NCT02999568

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

2.5 years

First QC Date

December 15, 2016

Last Update Submit

December 18, 2016

Conditions

Physical Exercise

Outcome Measures

Primary Outcomes (2)

  • Levels of anti-mullerian hormone

    3 days after period

  • Number of Antral Follicle Count

    3 days after period

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Experimental

Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years

Other: Physical exercise

Control group

Women who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years

Interventions

Physical exerciseOTHER

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

Experimental

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Control group - Recruitment will be done through Gynocologis tEmergency Experimental group - Recruitment will be done through sport centers

You may qualify if:

  • 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
  • BMI 18-25
  • Regular menstruation
  • 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
  • BMI 18-25
  • Regular menstruation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 7823386BACKGROUND

  • 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.

    PMID: 10740759BACKGROUND

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

    PMID: 21920880BACKGROUND

  • 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.

    PMID: 11880759BACKGROUND

  • 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.

    PMID: 20199120BACKGROUND

  • 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.

    PMID: 8567797BACKGROUND

  • 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.

    PMID: 8921059BACKGROUND

  • 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.

    PMID: 17012457BACKGROUND

  • 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.

    PMID: 24524834BACKGROUND

  • 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.

    PMID: 22287447BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yael Pasternak, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir Wiser, MD

CONTACT

07297472901Amir.Wiser@clalit.org.il

Helsinki Committee MMC

CONTACT

97297471588

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 21, 2016

Study Start

February 1, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

December 21, 2016

Record last verified: 2016-12