Status:
RECRUITING
CRD vs. Met in Patients With Obese PCOS Infertility
Lead Sponsor:
Shanghai First Maternity and Infant Hospital
Collaborating Sponsors:
RenJi Hospital
Shanghai 10th People's Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. From 2010 to 2020, it was found that the prevalenc...
Detailed Description
Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. Rotterdam criteria state the definition of PCOS is...
Eligibility Criteria
Inclusion
- a diagnosis of polycystic ovary syndrome (PCOS) based on the Rotterdam diagnostic criteria;
- age 20-35 years old;
- a body-mass index over 23;
- have requirements for fertility.
Exclusion
- acute or chronic viral hepatitis;
- serious liver dysfunction or chronic kidney disease;
- serious cardiovascular or cerebrovascular disease;
- patients with a history of acute/chronic infection, severe cardiovascular and cerebrovascular diseases, and malignant tumors;
- have drugs for PCOS such as glucocorticoids and anti-androgen drugs (spironolactone, cyproterone acetate, flutamide, etc.) within 3 months;
- congenital or secondary uterine abnormalities;
- use of medications that affect weight or energy balance such as Metformin within 3 months;
- undergoing weight loss treatment (weight change greater than 5% in the past 3 months) or have a history of gastrointestinal surgery;
- tubal obstruction;
- the total number of motile sperm of male partner is less than 10 million;
- any other situations that might affect the trial.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT06049186
Start Date
September 15 2023
End Date
March 31 2026
Last Update
September 22 2023
Active Locations (1)
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1
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 201204