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

NCT ID: NCT02848950

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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

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Infertility Female

Keywords

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Metformin fecundability uterine doppler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

drug: metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Supplementation of the study group with Metformin till the day of pregnancy confirmation

control

without metformin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metformin

Supplementation of the study group with Metformin till the day of pregnancy confirmation

Intervention Type DRUG

Other Intervention Names

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glucophage

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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nora gorhad

DOCTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JOHNNY YOUNIS, PEOFESSOR

Role: PRINCIPAL_INVESTIGATOR

Head of Fertility unit, Poriya' Bar Ilan University

Central Contacts

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nora gorhad shabso, doctor

Role: CONTACT

Email: [email protected]

Other Identifiers

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M.UTERUS.CTIL

Identifier Type: -

Identifier Source: org_study_id