RecruitingPhase 4NCT07242534

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

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


Sponsor

Fundacion Dexeus

Enrollment

62 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 38 Years

Inclusion Criteria4

  • ≤ 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 Criteria10

  • 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

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Interventions

DRUGSemaglutide

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.

OTHERNo pre-treatment

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.


Locations(5)

Dexeus Mujer Sabadell

Sabadell, Barcelona, Spain

Dexeus Mujer Sant Cugat

Sant Cugat del Vallès, Barcelona, Spain

Dexeus Mujer Reus

Reus, Tarragona, Spain

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, Spain

Dexeus Mujer Tarragona

Tarragona, Spain

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NCT07242534


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