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Trial · Interventional

RecruitingPhase 4Registry data

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

Short name SEQ

NCTNCT07242534 (opens ClinicalTrials.gov in a new tab)Other idFSD-SEM-2025-14Other id2025-522525-34-00Other id2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
62 participants (estimated)
Sponsor
Fundacion Dexeus · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
19 Jan 2026
Primary completion
Feb 2027 (estimated)
Completion
May 2027 (estimated)
First posted
21 Nov 2025
Last update posted
21 Jan 2026
Conditions
Infertility · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 4

    SEQ

    NCT07242534

    19 Jan 2026 to est. May 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • No pre-treatmentOther

Arms2

  • Experimental

    Semaglutide

    Semaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation

  • Active comparator

    No pre-treatment

    No pre-treatment prior to ovarian stimulation Pre-treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

    (ASEBIR criteria

Secondary outcomes(20)

  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

  5. Fertilization rate

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

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

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

  7. Time of pronuclei appearance (tPNa)

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

  8. Evaluation of both pronuclei (PN)

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

  9. Time of pronuclei disappearance (tPNf)

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

  10. Time of division from 2 to 8 cells

    Time frame · Tracked continuously via time-lapse, from Day 2 to Day 3 post-ICSI

  11. Time of compaction (tSC)

    Time frame · Tracked by time-lapse imaging on Day 4 post-ICSI

  12. Time of morula (tM)

    Time frame · Recorded by time-lapse on Day 4 post-ICSI.

  13. Time of cavitation (tSB)

    Time frame · Recorded by time-lapse on Day 5 post-ICSI.

  14. Time of full blastulation (tB)

    Time frame · Measured by time-lapse on Day 5 of embryo culture

  15. Total number of day 5 blastocysts

    Time frame · Counted on Day 5 of embryo culture after ICSI

  16. Blastocyst formation rate,

    Time frame · Calculated on Day 5 based on 2PN embryos reaching blastocyst stage.

    Registry description

    the proportion of 2PN zygotes that reach the blastocyst stage

  17. Number of embryos cryopreserved

    Time frame · Recorded at time of freezing on Day 5-7 of embryo culture

  18. Embryo stage (D5, D6, D7)

    Time frame · Assessed at time of embryo cryopreservation on Day 5 to 7

  19. Change in AFC

    Time frame · Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).

    Registry description

    before and after the treatment with semaglutide

  20. Change in AMH

    Time frame · Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).

    Registry description

    before and after the treatment with semaglutide

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2021

10 results

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Wilding et al. 2021The New England journal of medicinecited by 3,862

PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Randomized controlled trial · 2018

3 results

Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study.

Salamun et al. 2018European journal of endocrinologycited by 155

PMID 29703793DOI 10.1530/eje-18-0175PUB-29703793

Full text at the publisher3 results
Publisher pageSee results (3)

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Sundararaman et al. 2025Journal of clinical medicinecited by 6

PMID 40142784PMC11943310DOI 10.3390/jcm14061978PUB-40142784

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PubMed tag: none · 2023

Pharmacologic Treatment of Obesity in Reproductive Aged Women.

Nuako et al. 2023Current obstetrics and gynecology reportscited by 35

PMID 37427372PMC10328448DOI 10.1007/s13669-023-00350-1PUB-37427372

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Source link

Indexing hint: Review · 2023

Do GLP-1 Analogs Have a Place in the Treatment of PCOS? New Insights and Promising Therapies.

Szczesnowicz et al. 2023Journal of clinical medicinecited by 48

PMID 37762856PMC10532286DOI 10.3390/jcm12185915PUB-37762856

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Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 38 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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