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

Fundacion Dexeus

Status and phase: Enrolling; Phase 4

Conditions: Infertility; Obesity

Treatments: Other: No pre-treatment; Drug: Semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT07242534

FSD-SEM-2025-14

2025-522525-34-00 (EU Trial (CTIS) Number)

Details and patient eligibility

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.

Full description

Overweight and obese women (BMI 27-40 kg/m²) aged ≤38 years with adequate ovarian reserve (AMH ≥1 ng/mL or AFC ≥6) will be enrolled. Participants will be randomized in a 1:1 ratio to receive either 12 weeks of semaglutide pre-treatment (intervention group) or no pre-treatment (control group) before undergoing standard ovarian stimulation.

Embryos will be cultured to the blastocyst stage and cryopreserved (freeze-all strategy). In the semaglutide group, embryo transfer will occur after an 8-week washout from the last semaglutide dose.

Primary outcome: number of good-quality blastocysts on day 5. Secondary outcomes: embryo morphokinetics, fertilization rate, number of MII oocytes, number of COCs, total blastocyst formation rate, number of cryopreserved embryos, and pre/post semaglutide changes in weight, BMI, waist circumference, AMH, and AFC.

The study has been designed with a superiority hypothesis to detect a difference of 1.5 good-quality blastocysts between groups, with 80% power and a two-sided alpha of 0.05.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Semaglutide

Experimental group

Description:

Semaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation

Treatment:

Drug: Semaglutide

No pre-treatment

Active Comparator group

Description:

No pre-treatment prior to ovarian stimulation Pre-treatment

Treatment:

Other: No pre-treatment