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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai First Maternity and Infant Hospital
RECRUITING
Shanghai
Contact Information
Primary
Miaoxin Chen, Dr
chenmiaoxin@51mch.com
20261000
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 406
Treatments
Experimental: CRD group
Patients in the calorie-restricted diet (CRD) group will have strict calorie-restriction diets for 8 weeks and then weight stability for 4 weeks.
Active_comparator: Control group
Patients in the control group will receive regular diets and metformin 1500 mg daily for 12 weeks. Participants allocated to the control group are followed by the conventional approach (usual care) based on regular visits respecting the usual schedule dictated by the rules of general practice.
Sponsors
Collaborators: Shanghai 10th People's Hospital, RenJi Hospital
Leads: Shanghai First Maternity and Infant Hospital

This content was sourced from clinicaltrials.gov

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