The Effect of Weight Loss on Ovarian Reserve

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Amir Wiser, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01844128
First received: April 28, 2013
Last updated: June 10, 2013
Last verified: April 2013
  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 Meir Medical Center:

Primary Outcome Measures:
  • Anti Mullerain Hormone (AMH)and AFC before and after weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 43 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Amir Wiser, Senior physician IVF Unit, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01844128     History of Changes
Other Study ID Numbers: 0257-12mmc
Study First Received: April 28, 2013
Last Updated: June 10, 2013
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on September 18, 2014