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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility Female

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment<br>drug: metformin | Drug: Metformin<br>* Supplementation of the study group with Metformin till the day of pregnancy confirmation<br>* Other names: glucophage;|
| No Intervention: control<br>without metformin | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, fecundability, uterine doppler