Pre-conception care of diabetes, congenital malformations, and spontaneous abortions.
J L Kitzmiller, T A Buchanan, S Kjos...
https://pubmed.ncbi.nlm.nih.gov/8732721/Actively Recruiting
Led by Shandong University · Updated on 2024-05-29
988
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the effects of metformin pretreatment on reproductive outcomes in infertile women with prediabetes. The study aims to find out if starting metformin before ovarian stimulation or before frozen embryo transfer can increase the chances of a healthy live birth compared to placebo. This trial is a randomized, triple-blind study conducted by Shandong University focusing on women aged 20 to 40 years undergoing in-vitro fertilization IVF.
CONDITIONS
Effect of Metformin on Healthy Live Birth in Women With Prediabetes
Z
Zi-Jiang Chen, Professor
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Shandong University
Lead Sponsor
Ren Ji Hospital of Shanghai Jiao Tong University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 4 weeks until oocyte retrieval
Participants take metformin or placebo twice daily for at least 4 weeks before ovarian stimulation until oocyte retrieval.
1 baseline visit and visits during ovarian stimulation up to oocyte retrieval
Duration - At least 4 weeks before frozen embryo transfer until 7-8 weeks gestation
Participants take metformin or placebo twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and continue until clinical pregnancy is established (7-8 weeks gestation) after the first frozen embryo transfer.
Visits during endometrial preparation and early pregnancy monitoring
Duration - Up to 16 months from randomization until delivery
Participants are followed until delivery after the first embryo transfer to assess healthy live birth and pregnancy outcomes.
Regular follow-up visits until delivery
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/26908931/Shandong University
Lead Sponsor
Ren Ji Hospital of Shanghai Jiao Tong University
Collaborating Sponsor