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

Primary Purpose

Infertility Female

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metformin
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility Female focused on measuring Metformin, fecundability, uterine doppler

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    treatment

    control

    Arm Description

    drug: metformin

    without metformin

    Outcomes

    Primary Outcome Measures

    pregnancy rate

    Secondary Outcome Measures

    The changes in Doppler blood flow indices in both uterine arteries
    endometrial thickness change measured by millimeters
    Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows

    Full Information

    First Posted
    May 17, 2016
    Last Updated
    July 26, 2016
    Sponsor
    The Baruch Padeh Medical Center, Poriya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02848950
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility Female
    Keywords
    Metformin, fecundability, uterine doppler

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment
    Arm Type
    Active Comparator
    Arm Description
    drug: metformin
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    without metformin
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    glucophage
    Intervention Description
    Supplementation of the study group with Metformin till the day of pregnancy confirmation
    Primary Outcome Measure Information:
    Title
    pregnancy rate
    Time Frame
    until the blood test for pregnancy, about 4-6 weeks
    Secondary Outcome Measure Information:
    Title
    The changes in Doppler blood flow indices in both uterine arteries
    Time Frame
    until the blood test for pregnancy, about 4-6 weeks
    Title
    endometrial thickness change measured by millimeters
    Time Frame
    until the blood test for pregnancy, about 4-6 weeks
    Title
    Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows
    Time Frame
    until the blood test for pregnancy, about 4-6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    nora gorhad shabso, doctor
    Email
    ngorhad@poria.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JOHNNY YOUNIS, PEOFESSOR
    Organizational Affiliation
    Head of Fertility unit, Poriya' Bar Ilan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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