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

Baruch Padeh Medical Center

Status and phase: Unknown; Phase 2

Conditions: Infertility Female

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02848950

M.UTERUS.CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

treatment

Active Comparator group

Description:

drug: metformin

Treatment:

Drug: Metformin

control

No Intervention group

Description:

without metformin