Clinical trial NCT02848950: The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows
Official title: The Effect of Metformin on Fecundability in Obese Women Undergoing ART - the Correlation to Uterine Flow Parameters A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility Female
Keywords: Metformin
fecundability
uterine doppler
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2016-07-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pregnancy rate
timeFrame: until the blood test for pregnancy, about 4-6 weeks
Secondary outcomes:
measure: The changes in Doppler blood flow indices in both uterine arteries
timeFrame: until the blood test for pregnancy, about 4-6 weeks
measure: endometrial thickness change measured by millimeters
timeFrame: until the blood test for pregnancy, about 4-6 weeks
measure: Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows
timeFrame: until the blood test for pregnancy, about 4-6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Head of Fertility unit, Poriya' Bar Ilan University
name: JOHNNY YOUNIS, PEOFESSOR
role: PRINCIPAL_INVESTIGATOR
References: