Clinical trial NCT06775093: Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity
Official title: Effects of GLP-1 Receptor Agonists Combined with Metformin and Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Women with PCOS and Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Obesity
Infertility, Female
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 392
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

Detailed description: Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.

Eligibility criteria: Inclusion Criteria:

Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI\<35kg/m2;

Exclusion Criteria:

Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (\>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.

Primary outcomes:
measure: Live birth rate
timeFrame: 18 months
Secondary outcomes:
measure: BMI change from baseline to the 3rd month in kg/m2
timeFrame: 3 months
measure: Spontaneous resumption of ovulation
timeFrame: 3 months
measure: Clinical pregnancy
timeFrame: 9 months
measure: Ongoing pregnancy
timeFrame: 11 months
measure: Pregnancy loss
timeFrame: 18 months
measure: Gestational age at delivery
timeFrame: 18 months
measure: Time to pregnancy leading to live birth
timeFrame: 18 months
measure: Hypertensive disorders of pregnancy
timeFrame: 18 months
measure: Gestational diabetes
timeFrame: 18 months
measure: Birth weight in kg
timeFrame: 18 months
measure: Neonatal mortality
timeFrame: 18 months
measure: Major congenital anomaly
timeFrame: 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: