NCT02848950

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Baruch Padeh Medical Center, Poriya · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility Female

Interventions

Type	Name	Description
DRUG	Metformin	Supplementation of the study group with Metformin till the day of pregnancy confirmation

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-06-01
• Completion: 2017-07-01
• First posted: 2016-07-29
• Last updated: 2016-07-29