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Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity
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
Lead sponsor
Assets
Beinaglutide / GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
392
estimated
Study population
Obesity / overweight, PCOS, Reproductive / infertility
Key I/E criteria
•BMI ≤35•Female
Primary endpoint
•Live birth rate
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointBMI change from baseline to the 3rd month in kg/m2
Time frame:3 months
BMI, change
change from baseline, improvement
Glycemic / diabetes
1 endpointGestational diabetes
Time frame:18 months
categorical status, event
Safety / tolerability / PK
1 endpointMajor congenital anomaly
Time frame:18 months
event count, event
Other clinical outcomes
10 endpointsLive birth rate
Time frame:18 months
threshold achievement, event
Spontaneous resumption of ovulation
Time frame:3 months
Ovulation rate
categorical status, improvement
Clinical pregnancy
Time frame:9 months
categorical status, improvement
Ongoing pregnancy
Time frame:11 months
categorical status, event
Pregnancy loss
Time frame:18 months
event count, event
Gestational age at delivery
Time frame:18 months
descriptive
Time to pregnancy leading to live birth
Time frame:18 months
time to event, event
Hypertensive disorders of pregnancy
Time frame:18 months
categorical status, event
Birth weight in kg
Time frame:18 months
descriptive
Neonatal mortality
Time frame:18 months
time to event, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.