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The Effect of Weight Loss on Ovarian Reserve

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Amir Wiser, Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844128
First Posted: May 1, 2013
Last Update Posted: June 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amir Wiser, Meir Medical Center
  Purpose

Obesity affects on fertility. Obese women have lower pregnancy rate after infertility treatments.They need more doses of hormone during ovarian stimulation, more days for stimulation. During IVF treatment less oocytes are collected and the quality of embryo also harmed.

The first line treatment for those women with obesity and infertility is weight loss.

The investigators' hypothesis is that weight reduction improves ovarian reserve and fertility treatment outcome.


Condition Intervention
Weight Loss Dietary Supplement: weight loss

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year

Resource links provided by NLM:


Further study details as provided by Amir Wiser, Meir Medical Center:

Primary Outcome Measures:
  • Anti Mullerain Hormone (AMH)and AFC before and after weight loss [ Time Frame: 3 months ]
    AMH and AFC will measure at the first visit and after 3 months of weight loss program


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
overweight women with infertility Dietary Supplement: weight loss

Detailed Description:
The investigators have outpatient clinic for obesity and infertility. the patients undergoing program of 3 months with diet and physical activity. Blood sample will take at the beginning of the program and at the end. The blood sample will evaluate for: AMH, Adiponectin, Leptin, CRP, Colesterol, CRP, Smac in addition TVUS will perform to evaluate AFC.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Overweight women with infertility
Criteria

Inclusion Criteria:

  • undergoing weight loss program

Exclusion Criteria:

  • dropp out before comletion the weighy loss target
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844128


Contacts
Contact: Amir Wiswe, MD +97297472227

Locations
Israel
Meir Medical Center Recruiting
Kfar Sava, Israel
Contact: Overweight &Infertility clinic    097471555      
Principal Investigator: Amir Wiser, MD         
Sponsors and Collaborators
Meir Medical Center
  More Information

Responsible Party: Amir Wiser, Senior physician IVF Unit, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01844128     History of Changes
Other Study ID Numbers: 0257-12mmc
First Submitted: April 28, 2013
First Posted: May 1, 2013
Last Update Posted: June 11, 2013
Last Verified: April 2013

Keywords provided by Amir Wiser, Meir Medical Center:
MMA, AFC, Ovarian reserve

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms


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