Clinical trial NCT05702905: Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome
Official title: Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: PCOS (Polycystic Ovary Syndrome)
Semaglutide
Keywords: PCOS
semaglutide
obese
metabolic abnormality
fertility
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 75
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will be randomized into three groups: metformin single, semaglutide single, both metformin and semaglutide.
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.

Detailed description: To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. Metformin and semaglutide will be administered in a dose increasing mode, and then maintain until the end of 12 weeks, and metabolic related indexes will be evaluated. After 12 weeks of treatment, all subjects will stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks to evaluate the fertility related indicators. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

1. Meet the PCOS diagnostic criteria (Rotterdam）
2. Age 22-40
3. BMI ≥ 28 kg/m2
4. Infertility: having normal sexual life and failing to conceive without contraception for more than 1 year
5. Willing to be pregnant, and her husband has no serious infertility

Exclusion Criteria:

1. History of acute pancreatitis, individual or family history of medullary thyroid cancer and multiple endocrine adenomas
2. Type 1 diabetes and special type diabetes
3. History of tumor
4. Serious cardiovascular and cerebrovascular disease, mental disease, liver or kidney disease
5. Metformin, GLP-1 RA and other drugs affecting reproductive and metabolic functions were used within 90 days before the study
6. Known allergy to metformin, GLP-1 RA and excipients
7. Severe endometriosis, low ovarian reserve, premature ovarian failure
8. Inability to tolerate pregnancy and ovulation induction therapy
9. Other conditions considered unsuitable for this study by researchers

Primary outcomes:
measure: Percentage change in bodyweight at 12 weeks for semaglutide versus metformin
timeFrame: at the end of 12 weeks of treatment
measure: Achievement of weight reduction of at least 5% at 12 weeks for semaglutide versus metformin
timeFrame: at the end of 12 weeks of treatment
Secondary outcomes:
measure: HOMA-IR at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
measure: testosterone level at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
measure: androstenedione level at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
measure: FAI (Free Androgen Index) at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
Other outcomes:
measure: Depression score by self-rating depression scale (SDS）at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
measure: Anxiety score by self-rating anxiety scale (SAS）at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
measure: Diet score by TFEQ-18 (three factor eating questionaire) at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
measure: Quality of life score at 12 weeks of treatment
timeFrame: at the end of 12 weeks of treatment
measure: Ovulation rate at 24 weeks of follow-up after the end of treatment
timeFrame: at the end of 24 weeks of follow-up after the end of treatment
measure: Clinical pregnancy rate at 24 weeks of follow-up after the end of treatment
timeFrame: at the end of 24 weeks of follow-up after the end of treatment
measure: Cumulative pregnancy rate at 24 weeks of follow-up after the end of treatment
timeFrame: at the end of 24 weeks of follow-up after the end of treatment
Locations:
city: Peking
country: China
facility: PekingUFH
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Tingting Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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