Health TrialsbyHealthPanel

Effect of Metformin on Healthy Live Birth in Women With Prediabetes

ConditionsMetforminPrediabetesIn-Vitro Fertilization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorShandong University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Metformin pretreatment before ovarian stimulation

    Drug

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

  • Placebo pretreatment before ovarian stimulation

    Drug

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

  • Metformin pretreatment before endometrial preparation for frozen embryo transfer

    Drug

    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.

  • Placebo pretreatment before endometrial preparation for frozen embryo transfer

    Drug

    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.

Treatment groups

988 Participants
are divided into 4 treatment groups
Group A: Metformin-Metformin GroupExperimental treatment 2 interventions
Group B: Metformin-Placebo GroupExperimental treatment 2 interventions
Group C: Placebo-Metformin GroupExperimental treatment 2 interventions
Group D: Placebo-Placebo GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

healthy live birth

defined as a singleton live birth at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.

Time frame
From the date of randomization until delivery after the first embryo transfer, up to 16 months

Secondary outcomes

1

Change in BMI

change in body mass index (BMI) from baseline to the establishment of clinical pregnancy.

Time frame
From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks
2

Change in fasting glucose level

change in fasting glucose level from baseline to the establishment of clinical pregnancy.

Time frame
From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks
3

Change in fasting insulin level

change in fasting insulin level from baseline to the establishment of clinical pregnancy.

Time frame
From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks
4

Change in 2-h levels of glucose after 75-g OGTT

change in 2-h levels of glucose after 75-g OGTT from baseline to the establishment of clinical pregnancy.

Time frame
From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong University

Lead sponsor

Ren Ji Hospital of Shanghai Jiao Tong University

Collaborator

Women's Hospital of Zhejiang University

Collaborator

Shengjing Hospital

Collaborator

Nanjing Medical University

Collaborator

General Hospital of Ningxia Medical University

Collaborator

West China Second University Hospital

Collaborator

Henan Provincial Maternal and Child Health Care Hospital

Collaborator

Qingdao women's and children's Hospital

Collaborator

Source ClinicalTrials.gov
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