Effects of GLP-1RAs on Fertility Outcomes in Obese Women With PCOS

ConditionsPolycystic Ovary Syndrome (PCOS)Obesity Infertility, Female

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-40

SponsorPeking University Third Hospital

About this trial

The goal of this clinical trial is to examine whether GLP1-RA 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women with a wish to conceive;

Women with PCOS (Rotterdam criteria);

28 kg/m2≤BMI<35kg/m2;

Age: 18-40 years old

Disqualifiers

Women with diseases unsuitable for pregnancy or any other contraindications to infertility treatment 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 abnormalities that may affect assisted reproductive outcomes, untreated hydrosalpinx Male azoospermia, severe oligozoospermia and asthenospermia, or patients receiving donor sperm treatment Chromosomal abnormalities, patients planning preimplantation genetic testing (PGT) or donor oocyte treatment History of recurrent miscarriag Allergic to or contraindicated for GLP-1 class medications.

Trial design

Design model

Parallel

Treatments tested in this trial

GLP-1 receptor agonist
Drug
12 weeks treatment
Metformin
Drug
12 weeks treatment

Treatment groups

406 Participants

are divided into 2 treatment groups

Group A: Experimental: GLP-1 RAs combined with healthy lifestyle educationExperimental treatment 1 intervention

Group B: metformin and healthy lifestyle educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Ongoing Pregnancy Rate

Ongoing Pregnancy Rate (OPR) The percentage of embryo transfer cycles with an intrauterine pregnancy sustained beyond 20 gestational weeks, with a gestational sac and fetal cardiac activity confirmed via transvaginal ultrasound, out of all embryo transfer cycles.

Time frame

First cycle of IVF/ICSI-ET (the first frozen-thawed embryo transfer cycle if all embryos are cryopreserved after oocyte retrieval)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: