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

N/ANot Yet RecruitingNCT07687667

Peking University Third Hospital406 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

406

Conditions

Polycystic Ovary Syndrome (PCOS)Obesity Infertility, Female

Interventions

GLP-1 receptor agonistDRUG

12 weeks treatment

MetforminDRUG

12 weeks treatment

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women with a wish to conceive; * Women with PCOS (Rotterdam criteria); * 28 kg/m2≤BMI\<35kg/m2; * Age: 18-40 years old Exclusion Criteria: * 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.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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)

Central Contacts

Shuo Huang

CONTACT

+861082266699 homelyleaf@aliyun.com

Data from ClinicalTrials.gov

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