Effect of Metformin on Healthy Live Birth in Women With Prediabetes

Last updated: May 27, 2024
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Diabetes Prevention

Treatment

Placebo pretreatment before endometrial preparation for frozen embryo transfer

Metformin pretreatment before endometrial preparation for frozen embryo transfer

Placebo pretreatment before ovarian stimulation

Clinical Study ID

NCT06064669
MELT-PreDM
  • Ages 20-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT,or HbA1C 5.7-6.4%.

  2. Women aged 20-40 years.

  3. Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.

Exclusion

Exclusion Criteria:

  1. Women who are diagnosed with diabetes according to the ADA criteria11,12, which ismeeting one of the following criteria: fasting plasma glucose ≥7.0mmol/L, 2-h plasmaglucose during 75-g OGTT ≥11.1mmol/L, HbA1c≥6.5%, or a random plasmaglucose≥11.1mmol/L.

  2. Women who are taking medicine that interfere with glucose metabolism, such asmetformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months beforeenrollment.

  3. Women with un-corrected hyperthyroidism or hypothyroidism.

  4. Women with congenital or acquired abnormal uterine cavity including septate uterus,unicornous uterus, uterus duplex, and intrauterine adhesions.

  5. Women with a diagnosis of adenomyosis.

  6. Women with untreated hydrosalpinx.

  7. Women who plan to undergo PGT-SR or PGT-M.

  8. Women with major medical comorbidities, such as known liver disease, known renaldisease, or known significant anemia.

Study Design

Total Participants: 988
Treatment Group(s): 4
Primary Treatment: Placebo pretreatment before endometrial preparation for frozen embryo transfer
Phase:
Study Start date:
February 22, 2024
Estimated Completion Date:
December 31, 2027

Study Description

To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes and to determine whether either starting metformin pretreatment before ovarian stimulation (aiming at improving the quality of oocyte/embryo) or starting before frozen embryo transfer (FET) (aiming at improving the receptivity of endometrium) could increase the chance of a healthy live birth compared with placebo.

Connect with a study center

  • Shandong University

    Jinan, Shandong
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.