Effect of Metformin on Healthy Live Birth in Women With Prediabetes

Summary

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

Conditions

• Metformin
• Prediabetes
• In-Vitro Fertilization

Interventions

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.

Sponsors & Collaborators

• Ren Ji Hospital of Shanghai Jiao Tong University

  collaborator UNKNOWN

• Women's Hospital of Zhejiang University

  collaborator UNKNOWN

• Shengjing Hospital

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• West China Second University Hospital

  collaborator OTHER

• Maternal and Child Health Hospital of Henan Province

  collaborator UNKNOWN

• Qingdao women's and children's Hospital

  collaborator UNKNOWN

• Shandong University

  lead OTHER

Principal Investigators

• Zi-Jiang Chen, Professor · Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-22

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• China

Study Locations