The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows

July 26, 2016 updated by: nora gorhad, The Baruch Padeh Medical Center, Poriya

The Effect of Metformin on Fecundability in Obese Women Undergoing ART - the Correlation to Uterine Flow Parameters A Prospective Randomized Controlled Trial

The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.

Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.

It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.

This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age: from 18-40 years old.
  • BMI > 30
  • Infertile women undergoing frozen-thawed embryo transfer in an ART setting
  • Women with at least one Top graded embryo
  • Normal uterine Doppler indices at time of recruitment.

Exclusion Criteria:

  • Diabetes mellitus - uncontrolled.
  • Hyperprolactinemia- uncontrolled.
  • Hypothyroidism- uncontrolled.
  • women who are already treated with Metformin
  • women with endometrial factor as the cause for infertility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: treatment
drug: metformin
Drug: Metformin
Supplementation of the study group with Metformin till the day of pregnancy confirmation
Other Names:
  • glucophage
No Intervention: control
without metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: until the blood test for pregnancy, about 4-6 weeks
until the blood test for pregnancy, about 4-6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The changes in Doppler blood flow indices in both uterine arteries
Time Frame: until the blood test for pregnancy, about 4-6 weeks
until the blood test for pregnancy, about 4-6 weeks
endometrial thickness change measured by millimeters
Time Frame: until the blood test for pregnancy, about 4-6 weeks
until the blood test for pregnancy, about 4-6 weeks
Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows
Time Frame: until the blood test for pregnancy, about 4-6 weeks
until the blood test for pregnancy, about 4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Investigators

  • Principal Investigator: JOHNNY YOUNIS, PEOFESSOR, Head of Fertility unit, Poriya' Bar Ilan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M.UTERUS.CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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