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

Phase 2

• Conditions: Infertility Female
• Interventions: Drug: Metformin

• Registration Number: NCT02848950
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-05-17
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-29
• Last Update Posted: 2016-07-29
• Study Start: 2016-08
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment	Metformin	drug: metformin

Primary Outcome Measures

Name	Time	Method
pregnancy rate	until the blood test for pregnancy, about 4-6 weeks

Secondary Outcome Measures

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