Clinical trial

Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization.

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07242534

Recruiting nowPhase 4Interventional

What this study is about

This is a randomized, controlled clinical trial with a two-sided superiority hypothesis. The study evaluates whether a 12-week pre-treatment with semaglutide prior to ovarian stimulation improves the number of good-quality blastocysts in overweight and obese women undergoing in vitro fertilization (IVF), compared to no pre-treatment.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 38 Years

SexFemale

Healthy volunteersNot accepted

ConditionInfertility, Obesity

Full registry criteria

Inclusion Criteria: * ≤ 38 years * AMH \>= 1 ng/mL or AFC \>= 6 * Body mass index (BMI) between 27 kg/m2 and 40 kg/m2 * Scheduled for IVF with freeze-all strategy Exclusion Criteria: * Severe male factor (sperm concentration \<5M/mL) * Type 2 diabetes mellitus * Prior use of GLP-1 Ras within the past year * Uncontrolled thyroid disorders * Contraindications to IVF or semaglutide treatment * Patients with chronic inflammatory diseases * Family history of hereditary or chromosomal diseases * Use of glucocorticoids or immunosuppressants * PGT-A * Use of medications affecting metabolism or inflammation

Treatments and study arms

Semaglutide

Drug

Participants in this group will receive semaglutide for 12 weeks before ovarian stimulation (0.25 mg/week in weeks 1-4, 0.5 mg/week in weeks 5-8, and 1 mg/week in weeks 9-12). After pre-treatment, controlled ovarian stimulation will be initiated with 225-300 IU/day of rFSH, GnRH antagonist (0.25 mg/day) starting when follicles reach ≥14 mm, and ovulation triggered with triptorelin 0.2 mg when 2-3 follicles reach ≥18 mm. Oocyte retrieval will occur 34-36 hours later, followed by IVF/ICSI. Embryos will be cultured to blastocyst stage and cryopreserved. Embryo transfer will occur after an 8-week washout from semaglutide.

No pre-treatment

Other

Participants in this group will undergo standard ovarian stimulation without semaglutide pre-treatment. Stimulation will begin with 225-300 IU/day of rFSH, GnRH antagonist (0.25 mg/day) starting when follicles reach ≥14 mm, and ovulation triggered with triptorelin 0.2 mg when 2-3 follicles reach ≥18 mm. Oocyte retrieval will be performed 34-36 hours later, followed by IVF/ICSI. Embryos will be cultured to the blastocyst stage and cryopreserved. Embryo transfer will follow standard clinical practice.

Primary outcomes

Number of good quality blastocysts (GQB)Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage.

(ASEBIR criteria