Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization. A Randomized Controlled Trial
- Conditions
- InfertilityObesity
- Interventions
- Other: No pre-treatment
- Registration Number
- NCT07242534
- Lead Sponsor
- Fundacion Dexeus
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 62
- ≤ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide Semaglutide Semaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation No pre-treatment No pre-treatment No pre-treatment prior to ovarian stimulation Pre-treatment
- Primary Outcome Measures
Name Time Method Number of good quality blastocysts (GQB) Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage. (ASEBIR criteria
- Secondary Outcome Measures
Name Time Method Days of stimulation From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant. Total dose of Gonadotropins From first day of ovarian stimulation to trigger day (8-12 days total). Number COCs Assessed on day of oocyte retrieval, approx. 34-36 hours after ovulation trigger. Number MII Assessed on same day as oocyte retrieval, after denudation and classification Fertilization rate Assessed on Day 1 after ICSI, 16-18 hours post-injection Time of appearance of the 2nd polar body (tPB2) Recorded via time-lapse system, within first 8 hours post-ICSI (Day 0). Time of pronuclei appearance (tPNa) Measured on Day 1 post-ICSI using time-lapse monitoring. Evaluation of both pronuclei (PN) Assessed during pronuclear stage on Day 1 post-ICSI. Time of pronuclei disappearance (tPNf) Recorded by time-lapse imaging, approx. 20-24 hours post-ICSI. Time of division from 2 to 8 cells Tracked continuously via time-lapse, from Day 2 to Day 3 post-ICSI Time of compaction (tSC) Tracked by time-lapse imaging on Day 4 post-ICSI Time of morula (tM) Recorded by time-lapse on Day 4 post-ICSI. Time of cavitation (tSB) Recorded by time-lapse on Day 5 post-ICSI. Time of full blastulation (tB) Measured by time-lapse on Day 5 of embryo culture Total number of day 5 blastocysts Counted on Day 5 of embryo culture after ICSI Blastocyst formation rate, Calculated on Day 5 based on 2PN embryos reaching blastocyst stage. the proportion of 2PN zygotes that reach the blastocyst stage
Number of embryos cryopreserved Recorded at time of freezing on Day 5-7 of embryo culture Embryo stage (D5, D6, D7) Assessed at time of embryo cryopreservation on Day 5 to 7 Change in AFC Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12). before and after the treatment with semaglutide
Change in AMH Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12). before and after the treatment with semaglutide
Change in BMI : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5). before and after the treatment with semaglutide
Change in WC : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5). before and after the treatment with semaglutide
Trial Locations
- 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
Dexeus Mujer Sabadell🇪🇸Sabadell, Barcelona, SpainAinhoa Coco, MDPrincipal Investigator