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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Dexeus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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