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NCT01844128 Clinical Trial

The Effect of Weight Loss on Ovarian Reserve

Weight Loss Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01844128
Other study ID # 0257-12mmc
Secondary ID
Status Recruiting
Phase N/A
First received April 28, 2013
Last updated June 10, 2013
Start date May 2013

Study information
Verified date April 2013
Source Meir Medical Center
Contact Amir Wiswe, MD
Phone +97297472227
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 43 Years
Eligibility Inclusion Criteria:

- undergoing weight loss program

Exclusion Criteria:

- dropp out before comletion the weighy loss target

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• weight loss

Locations
Country Name City State
Israel Meir Medical Center Kfar Sava

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anti Mullerain Hormone (AMH)and AFC before and after weight loss AMH and AFC will measure at the first visit and after 3 months of weight loss program 3 months No
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