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

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ClinicalTrials.gov Identifier: NCT02848950
Recruitment Status : Not yet recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
nora gorhad, The Baruch Padeh Medical Center, Poriya

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.


Condition or disease Intervention/treatment Phase
Infertility Female Drug: Metformin Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: treatment
drug: metformin
Drug: Metformin
Supplementation of the study group with Metformin till the day of pregnancy confirmation
Other Name: glucophage
No Intervention: control
without metformin



Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]

Secondary Outcome Measures :
  1. The changes in Doppler blood flow indices in both uterine arteries [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]
  2. endometrial thickness change measured by millimeters [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]
  3. Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows [ Time Frame: until the blood test for pregnancy, about 4-6 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848950


Contacts
Contact: nora gorhad shabso, doctor ngorhad@poria.health.gov.il

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Principal Investigator: JOHNNY YOUNIS, PEOFESSOR Head of Fertility unit, Poriya' Bar Ilan University

Responsible Party: nora gorhad, DOCTOR, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT02848950     History of Changes
Other Study ID Numbers: M.UTERUS.CTIL
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by nora gorhad, The Baruch Padeh Medical Center, Poriya:
Metformin
fecundability
uterine doppler

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs