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

Infertility Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02848950
• Other study ID #: M.UTERUS.CTIL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 17, 2016
• Last updated: July 26, 2016
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: nora gorhad shabso, doctor
• Email: ngorhad[@]poria.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility Female
• Infertility, Female

Intervention

Drug:
• Metformin
Supplementation of the study group with Metformin till the day of pregnancy confirmation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate		until the blood test for pregnancy, about 4-6 weeks	Yes
Secondary	The changes in Doppler blood flow indices in both uterine arteries		until the blood test for pregnancy, about 4-6 weeks	No
Secondary	endometrial thickness change measured by millimeters		until the blood test for pregnancy, about 4-6 weeks	No
Secondary	Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows		until the blood test for pregnancy, about 4-6 weeks	No