NCT01844128

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

June 11, 2013

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

April 28, 2013

Last Update Submit

June 10, 2013

Conditions

Weight Loss

Keywords

MMA, AFC, Ovarian reserve

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

overweight women with infertility

Dietary Supplement: weight loss

Interventions

weight lossDIETARY_SUPPLEMENT
overweight women with infertility

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Overweight women with infertility

You may qualify if:

  • undergoing weight loss program

You may not qualify if:

  • dropp out before comletion the weighy loss target

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Amir Wiswe, MD

CONTACT

+97297472227

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician IVF Unit

Study Record Dates

First Submitted

April 28, 2013

First Posted

May 1, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2014

Last Updated

June 11, 2013

Record last verified: 2013-04

Locations

IL(1)