Semaglutide before IVF to improve embryo quality for overweight and obese women

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

This trial tests whether 12 weeks of semaglutide before ovarian stimulation helps overweight and obese women produce more good-quality blastocysts than no pre-treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 38 Years
• Sex: Female
• Sponsor: Fundacion Dexeus (Academic / other)
• Locations: 5 sites (Sabadell, Barcelona and 4 other locations)
• Trial ID: NCT07242534 on ClinicalTrials.gov

What this trial studies

Overweight and obese women up to 38 years old with preserved ovarian reserve (AMH ≥1 ng/mL or AFC ≥6) and BMI 27–40 kg/m² are randomized 1:1 to 12 weeks of semaglutide pre-treatment or no pre-treatment before standard ovarian stimulation. Embryos are cultured to blastocyst stage and cryopreserved using a freeze-all strategy, with transfers in the semaglutide group after an 8-week washout. The primary outcome is the number of good-quality blastocysts on day 5, and secondary outcomes include fertilization rate, embryo morphokinetics, numbers of MII oocytes and COCs, total blastocyst formation rate, and metabolic changes. The study is powered to detect a difference of 1.5 good-quality blastocysts between groups with 80% power and a two-sided alpha of 0.05.

Who should consider this trial

Good fit: Overweight or obese women (BMI 27–40 kg/m²) aged 38 or younger with adequate ovarian reserve (AMH ≥1 ng/mL or AFC ≥6) who are planning IVF with a freeze-all approach are the intended participants.

Not a fit: Women with severe male factor infertility, type 2 diabetes, recent GLP-1 use, uncontrolled thyroid disease, chronic inflammatory conditions, or those planning PGT-A are excluded and unlikely to benefit from this semaglutide pre-treatment approach in this trial.

Why it matters

Potential benefit: If successful, pre-treatment with semaglutide could increase the number of good-quality blastocysts and potentially improve IVF success for overweight and obese patients.

How similar studies have performed: Semaglutide and other GLP-1 receptor agonists have strong evidence for weight loss and metabolic improvement, but direct proof that they improve embryo quality in IVF is limited and this application is relatively novel.

Eligibility 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

Where this trial is running

Sabadell, Barcelona and 4 other locations

• Dexeus Mujer Sabadell — Sabadell, Barcelona, Spain (Not_yet_recruiting)
• Dexeus Mujer Sant Cugat — Sant Cugat del Vallès, Barcelona, Spain (Not_yet_recruiting)
• Dexeus Mujer Reus — Reus, Tarragona, Spain (Not_yet_recruiting)
• Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus — Barcelona, Spain (Recruiting)
• Dexeus Mujer Tarragona — Tarragona, Spain (Not_yet_recruiting)

Study contacts

• Principal investigator: Nikolaos P Polyzos, MD, PhD — Dexeus Fertility
• Study coordinator: Nikolaos P Polyzos, MD, PhD

Conditions Infertility; Obesity; Overweight; GLP-1 receptor agonist; IVF; ART