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

B

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)

100 participants in 2 patient groups

treatment
Active Comparator group
Description:
drug: metformin
Treatment:
Drug: Metformin
control
No Intervention group
Description:
without metformin

Trial contacts and locations

0

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Central trial contact

nora gorhad shabso, doctor

Data sourced from clinicaltrials.gov

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