CRD vs. Met in Patients With Obese PCOS Infertility

Shanghai First Maternity and Infant Hospital

Status: Enrolling

Conditions: Polycystic Ovary Syndrome

Treatments: Behavioral: CRD; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06049186

CRD vs. Met in PCOS

Details and patient eligibility

About

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.

Full 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 that women must present with two of the following three signs/symptoms-hyperandrogenism, chronic anovulation/oligomenorrhea, and polycystic ovaries-in the absence of other diseases that promote these symptoms. 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. This research is aimed to evaluate whether CRD intervention prior to ovulation induction could promote reproductive health in overweight or obese PCOS women with fertility requirements and provide an evidence-based nutrition advice for clinical practice.

Enrollment: 406 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. a diagnosis of polycystic ovary syndrome (PCOS) based on the Rotterdam diagnostic criteria;
2. age 20-35 years old;
3. a body-mass index over 23;
4. have requirements for fertility.

Exclusion criteria

1. acute or chronic viral hepatitis;
2. serious liver dysfunction or chronic kidney disease;
3. serious cardiovascular or cerebrovascular disease;
4. patients with a history of acute/chronic infection, severe cardiovascular and cerebrovascular diseases, and malignant tumors;
5. have drugs for PCOS such as glucocorticoids and anti-androgen drugs (spironolactone, cyproterone acetate, flutamide, etc.) within 3 months;
6. congenital or secondary uterine abnormalities;
7. use of medications that affect weight or energy balance such as Metformin within 3 months;
8. undergoing weight loss treatment (weight change greater than 5% in the past 3 months) or have a history of gastrointestinal surgery;
9. tubal obstruction;
10. the total number of motile sperm of male partner is less than 10 million;
11. any other situations that might affect the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

CRD group

Experimental group

Description:

Patients in the calorie-restricted diet (CRD) group will have strict calorie-restriction diets for 8 weeks and then weight stability for 4 weeks.

Treatment:

Behavioral: CRD

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin