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

January 19, 2026 updated by: Fundacion Dexeus

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ignacio Rodríguez, MSc
  • Phone Number: 22029 0034932274700
  • Email: nacrod@dexeus.com

Study Contact Backup

  • Name: Nikolaos P Polyzos, MD, PhD
  • Phone Number: 0034932274700
  • Email: nikpol@dexeus.com

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
        • Contact:
        • Sub-Investigator:
          • Valeria Donno, MD
      • Tarragona, Spain, 43206
        • Not yet recruiting
        • Dexeus Mujer Tarragona
        • Contact:
        • Principal Investigator:
          • Josep Gonzalo, MD
    • Barcelona
      • Sabadell, Barcelona, Spain
        • Not yet recruiting
        • Dexeus Mujer Sabadell
        • Contact:
        • Principal Investigator:
          • Ainhoa Coco, MD
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Not yet recruiting
        • Dexeus Mujer Sant Cugat
        • Contact:
        • Principal Investigator:
          • Ainhoa Coco, MD
    • Tarragona
      • Reus, Tarragona, Spain, 43202
        • Not yet recruiting
        • Dexeus Mujer Reus
        • Contact:
        • Principal Investigator:
          • Josep Gonzalo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide
Semaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation
Drug: Semaglutide
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.
Active Comparator: No pre-treatment
No pre-treatment prior to ovarian stimulation Pre-treatment
Other: No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of good quality blastocysts (GQB)
Time Frame: Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage.
(ASEBIR criteria
Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of stimulation
Time Frame: From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant.
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).
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.
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
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
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).
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.
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.
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.
Recorded by time-lapse imaging, approx. 20-24 hours post-ICSI.
Time of division from 2 to 8 cells
Time Frame: Tracked continuously via time-lapse, from Day 2 to Day 3 post-ICSI
Tracked continuously via time-lapse, from Day 2 to Day 3 post-ICSI
Time of compaction (tSC)
Time Frame: Tracked by time-lapse imaging on Day 4 post-ICSI
Tracked by time-lapse imaging on Day 4 post-ICSI
Time of morula (tM)
Time Frame: Recorded by time-lapse on Day 4 post-ICSI.
Recorded by time-lapse on Day 4 post-ICSI.
Time of cavitation (tSB)
Time Frame: Recorded by time-lapse on Day 5 post-ICSI.
Recorded by time-lapse on Day 5 post-ICSI.
Time of full blastulation (tB)
Time Frame: Measured by time-lapse on Day 5 of embryo culture
Measured by time-lapse on Day 5 of embryo culture
Total number of day 5 blastocysts
Time Frame: Counted on Day 5 of embryo culture after ICSI
Counted on Day 5 of embryo culture after ICSI
Blastocyst formation rate,
Time Frame: Calculated on Day 5 based on 2PN embryos reaching blastocyst stage.
the proportion of 2PN zygotes that reach the blastocyst stage
Calculated on Day 5 based on 2PN embryos reaching blastocyst stage.
Number of embryos cryopreserved
Time Frame: Recorded at time of freezing on Day 5-7 of embryo culture
Recorded at time of freezing on Day 5-7 of embryo culture
Embryo stage (D5, D6, D7)
Time Frame: Assessed at time of embryo cryopreservation on Day 5 to 7
Assessed at time of embryo cryopreservation on Day 5 to 7
Change in AFC
Time Frame: Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
before and after the treatment with semaglutide
Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
Change in AMH
Time Frame: Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
before and after the treatment with semaglutide
Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
Change in BMI
Time Frame: : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).
before and after the treatment with semaglutide
: Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).
Change in WC
Time Frame: : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).
before and after the treatment with semaglutide
: Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Dexeus

Investigators

  • Principal Investigator: Nikolaos P Polyzos, MD, PhD, Dexeus Fertility

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSD-SEM-2025-14
  • 2025-522525-34-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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