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

Phase 4RecruitingNCT07242534

Fundacion Dexeus62 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility Obesity

Interventions

SemaglutideDRUG

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-treatmentOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 38 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Number of good quality blastocysts (GQB)

(ASEBIR criteria

Time frame: Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage.

Secondary Outcomes

Days of stimulation

Time frame: From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant.

Total dose of Gonadotropins

Time frame: From first day of ovarian stimulation to trigger day (8-12 days total).

Number COCs

Time frame: Assessed on day of oocyte retrieval, approx. 34-36 hours after ovulation trigger.

Number MII

Time frame: Assessed on same day as oocyte retrieval, after denudation and classification

Fertilization rate

Time frame: Assessed on Day 1 after ICSI, 16-18 hours post-injection

Time of appearance of the 2nd polar body (tPB2)

Time frame: Recorded via time-lapse system, within first 8 hours post-ICSI (Day 0).

Time of pronuclei appearance (tPNa)

Time frame: Measured on Day 1 post-ICSI using time-lapse monitoring.

Evaluation of both pronuclei (PN)

Time frame: Assessed during pronuclear stage on Day 1 post-ICSI.

Time of pronuclei disappearance (tPNf)

Time frame: Recorded by time-lapse imaging, approx. 20-24 hours post-ICSI.

Central Contacts

Nikolaos P Polyzos, MD, PhD

CONTACT

0034932274700 nikpol@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700 nacrod@dexeus.com

Data from ClinicalTrials.gov

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