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

ConditionsInfertilityObesity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorFundacion Dexeus

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≤ 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

Disqualifiers

Severe male factor (sperm concentration <5M/mL)

Type 2 diabetes mellitus

Prior use of GLP-1 Ras within the past year

Uncontrolled thyroid disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 1 intervention
Group B: No pre-treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Days of stimulation

Time frame
From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant.
2

Total dose of Gonadotropins

Time frame
From first day of ovarian stimulation to trigger day (8-12 days total).
3

Number COCs

Time frame
Assessed on day of oocyte retrieval, approx. 34-36 hours after ovulation trigger.
4

Number MII

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Dexeus

Lead sponsor

Source ClinicalTrials.gov
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