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

NCT02848950 | Unknown Phase 2

• 1 other identifier: M.UTERUS.CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility Female

Keywords

Metformin; fecundability; uterine doppler

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  until the blood test for pregnancy, about 4-6 weeks

Secondary Outcomes (3)

• The changes in Doppler blood flow indices in both uterine arteries

  until the blood test for pregnancy, about 4-6 weeks

• endometrial thickness change measured by millimeters

  until the blood test for pregnancy, about 4-6 weeks

• Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows

  until the blood test for pregnancy, about 4-6 weeks

Study Arms (2)

treatment

ACTIVE COMPARATOR

drug: metformin

Drug: Metformin

control

NO INTERVENTION

without metformin

Interventions

Metformin DRUG

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

Also known as: glucophage

treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diabetes mellitus - uncontrolled.
• Hyperprolactinemia- uncontrolled.
• Hypothyroidism- uncontrolled.
• women who are already treated with Metformin
• women with endometrial factor as the cause for infertility

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

MeSH Terms

Conditions

Infertility, Female

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• JOHNNY YOUNIS, PEOFESSOR

  Head of Fertility unit, Poriya' Bar Ilan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nora gorhad shabso, doctor

CONTACT

ngorhad@poria.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: July 29, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share