Preconception diabetes mellitus and adverse pregnancy outcomes in over 6.4 million women: A population-based cohort study in China.
Yumei Wei, Qin Xu, Huixia Yang...
https://pubmed.ncbi.nlm.nih.gov/31574092Actively Recruiting
Phase Not Applicable
Age: 20Years - 40Years
FEMALE
Healthy Volunteers
ID06064669
Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial
Led by Shandong University · Updated on 2024-05-29
988
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Shandong University
Lead Sponsor
R
Ren Ji Hospital of Shanghai Jiao Tong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Effect of Metformin on Healthy Live Birth in Women With Prediabetes
Who Can Participate
Age: 20Years - 40Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women diagnosed with prediabetes by ADA criteria, including impaired fasting glucose, impaired glucose tolerance, or HbA1C 5.7-6.4%.
- Women aged 20 to 40 years.
- Women planning to undergo a new cycle of IVF, ICSI, or PGT-A.
You will not qualify if you...
- Women diagnosed with diabetes by ADA criteria (fasting plasma glucose 67.0mmol/L, 2-hour plasma glucose 611.1mmol/L during 75-g OGTT, HbA1c 6.5%, or random plasma glucose 611.1mmol/L).
- Women taking medications that affect glucose metabolism, such as metformin, oral anti-diabetic agents, weight loss drugs, glucocorticoids, or growth hormones within 2 months before enrollment.
- Women with untreated hyperthyroidism or hypothyroidism.
- Women with congenital or acquired uterine abnormalities including septate, unicornous, duplex uterus, or intrauterine adhesions.
- Women diagnosed with adenomyosis.
- Women with untreated hydrosalpinx.
- Women planning to undergo PGT-SR or PGT-M.
- Women with major medical conditions like known liver disease, renal disease, or significant anemia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
Shandong University
Jinan, Shandong, China
Actively Recruiting
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Research Team
Z
Zi-Jiang Chen, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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