NCT06049186

CRD vs. Met in Patients With Obese PCOS Infertility

Name: Clinical Trial NCT06049186
Creator: Shanghai First Maternity and Infant Hospital
Keywords: Polycystic Ovary Syndrome, CRD, behavioral, clinical trial, China

Comparison of Live Birth Rates Between Calorie-restricted Diets and Metformin Interventions Prior to Ovulation Induction Therapy in Patients With Overweight/Obese Polycystic Ovary Syndrome Combined With Infertility

Shanghai First Maternity and Infant Hospital·ClinicalTrials.gov·behavioralRecruiting

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Study focus

Disease/Condition: Polycystic Ovary Syndrome
Drug/Device/Intervention: CRD
Study type: Interventional
Intervention type: behavioral

Sponsor & location

Primary sponsor: Shanghai First Maternity and Infant Hospital
Location: Shanghai, China

Timeline & enrollment

Phase: N/A
Start date: Sep 15, 2023
End date: Mar 31, 2026
Enrollment: 406 participants

Primary outcome

Live birth during the period of ovulation induction

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 prevalence of PCOS in reproductive-aged women in China reached 7.8%, an increase of 65% over 10 years ago. Many of them are overweight or obese. Weight loss including diet modifications can significantly reduce reproductive and metabolic disorders of PCOS and is recommended as a first step in the treatment of overweight or obese women with PCOS. Many weight loss programs have been proposed, including calorie-restriction diet (CRD) intervention. Whether CRD intervention prior to ovulation induction therapy could improve live birth rates in overweight/obese PCOS women has not been illustrated.

ICD-10 classifications

Polycystic ovarian syndromeOvarian dysfunction, unspecifiedOvarian dysfunctionOther ovarian dysfunctionNeoplasm of uncertain or unknown behaviour: Ovary

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06049186
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06049186 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai First Maternity and Infant Hospital and is currently Recruiting. The study focuses on Polycystic Ovary Syndrome. Target enrollment is 406 participants.

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