Actively Recruiting

Phase Not Applicable
Age: 20Years - 40Years
FEMALE
Healthy Volunteers
NCT06064669

Effect of Metformin on Healthy Live Birth in Women With Prediabetes

Led by Shandong University · Updated on 2024-05-29

988

Participants Needed

1

Research Sites

201 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

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

CONDITIONS

Official Title

Effect of Metformin on Healthy Live Birth in Women With Prediabetes

Who Can Participate

Age: 20Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women diagnosed with prediabetes by ADA criteria, including IFG, IGT, 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
Not Eligible

You will not qualify if you...

  • Women diagnosed with diabetes by ADA criteria (fasting plasma glucose ≥7.0 mmol/L, 2-hour plasma glucose ≥11.1 mmol/L, HbA1c ≥6.5%, or random plasma glucose ≥11.1 mmol/L)
  • Women taking medicines that affect glucose metabolism (e.g., metformin, oral anti-diabetic agents, weight loss drugs, glucocorticoids, growth hormones) within 2 months before enrollment
  • Women with untreated hyperthyroidism or hypothyroidism
  • Women with congenital or acquired abnormal uterine cavity (e.g., septate uterus, unicornous uterus, uterus duplex, intrauterine adhesions)
  • Women diagnosed with adenomyosis
  • Women with untreated hydrosalpinx
  • Women planning to undergo PGT-SR or PGT-M
  • Women with major medical comorbidities such as known liver disease, renal disease, or significant anemia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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