RecruitingNot ApplicableNCT06064669

Effect of Metformin on Healthy Live Birth in Women With Prediabetes

Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial


Sponsor

Shandong University

Enrollment

988 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Inclusion Criteria3

  • Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.
  • Women aged 20-40 years.
  • Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.

Exclusion Criteria8

  • Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol/L, 2-h plasma glucose during 75-g OGTT ≥11.1mmol/L, HbA1c≥6.5%, or a random plasma glucose≥11.1mmol/L.
  • Women who are taking medicine that interfere with glucose metabolism, such as metformin, 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 before enrollment.
  • Women with un-corrected hyperthyroidism or hypothyroidism.
  • Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.
  • Women with a diagnosis of adenomyosis.
  • Women with untreated hydrosalpinx.
  • Women who plan to undergo PGT-SR or PGT-M.
  • Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.

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Interventions

DRUGMetformin pretreatment before ovarian stimulation

The enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval.

DRUGPlacebo pretreatment before ovarian stimulation

The enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval.

DRUGMetformin pretreatment before endometrial preparation for frozen embryo transfer

After oocyte retrieval, the enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.

DRUGPlacebo pretreatment before endometrial preparation for frozen embryo transfer

After oocyte retrieval, the enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer.


Locations(1)

Shandong University

Jinan, Shandong, China

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NCT06064669


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