NCT06064669

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 988 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Metformin
• Prediabetes
• In-Vitro Fertilization

Interventions

Type	Name	Description
DRUG	Metformin 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.
DRUG	Placebo 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.
DRUG	Metformin 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.
DRUG	Placebo 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.

Timeline

• Start date: 2024-02-22
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-10-03
• Last updated: 2024-05-29

Locations

1 site across 1 country: China