CClinicalTrials.gg
Status unknownNCT02848950Updated Jul 29, 2016

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

A Phase 2 interventional study of Metformin in Infertility Female, sponsored by The Baruch Padeh Medical Center, Poriya. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-07-29.

Sponsored by The Baruch Padeh Medical Center, Poriya · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility Female

Keywords

  • Metformin
  • fecundability
  • uterine doppler
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

The Baruch Padeh Medical Center, Poriya is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    treatment

    drug: metformin

    Drug: Metformin

  • No intervention
    control

    without metformin

Interventions

  • DrugMetformin

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

    Also known as: glucophage

06

What researchers measure

Primary outcomes

  1. pregnancy rate

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

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02848950
Lead sponsor
The Baruch Padeh Medical Center, Poriya
Responsible party
nora gorhad (DOCTOR, The Baruch Padeh Medical Center, Poriya) — Principal investigator
First posted
Jul 29, 2016
Start date
Aug 2016
Primary completion
Jun 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
Jul 29, 2016

Study contacts

nora gorhad shabso, doctor
Contact
ngorhad@poria.health.gov.il
JOHNNY YOUNIS, PEOFESSOR
principal investigator · Head of Fertility unit, Poriya' Bar Ilan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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