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Physical ExerciseNCT02999568

The Effect of Exercise on Ovarian Reserve

An observational study of Physical Exercise, run by Meir Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Exercise
What is being tested?
Physical exercise
How many people
100 participants
Where
No sites listed yet
Study dates
Feb 2017to Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Amir Wiser, MD contact

07297472901

Amir.Wiser@clalit.org.il

Helsinki Committee MMC contact

97297471588

About this study

Official title: 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

Read the 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.
Being tested
Physical exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT02999568
Study groupRoleWhat they receive
ExperimentalWomen who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
Receives: Other: Physical exercise
Control groupWomen who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Levels of anti-mullerian hormone

    Measured: 3 days after period

  2. Number of Antral Follicle Count

    Measured: 3 days after period

Secondary outcomes (9)

  1. Levels of Follicle-stimulating hormone

    Measured: 3 days after period

  2. levels fo Luteinizing hormone

    Measured: 3 days after period

  3. Levels of progesterone

    Measured: 3 days after period

  4. Levels of estradiol

    Measured: 3 days after period

  5. Levels of Thyroid-stimulating hormone

    Measured: 3 days after period

  6. Levels of leptin

    Measured: 3 days after period

  7. Menstrual duration

    Measured: 3 days after period

  8. frequency of bleeding in every menstruation

    Measured: 3 days after period

  9. amount of bleeding in every menstruation

    Measured: 3 days after period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study startFeb 2017
  3. Primary completionAug 2019 (estimated)
  4. Study completionAug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02999568
Sponsor's protocol ID
Meir Medical Center - Sport
Status last verified
Dec 2016
First submitted
15 Dec 2016
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 7823386

  • 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.

    PubMed 10740759

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

    PubMed 21920880

  • 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.

    PubMed 11880759

  • 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.

    PubMed 20199120

  • 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.

    PubMed 8567797

  • 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.

    PubMed 8921059

  • 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.

    PubMed 17012457

  • 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.

    PubMed 24524834

  • 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.

    PubMed 22287447

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Exercise, run by Meir Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amir Wiser, MD (07297472901, Amir.Wiser@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of anti-mullerian hormone (time frame: 3 days after period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02999568, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.

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