Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07242534

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Infertility Body Weight Genital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dexeus Mujer Sabadell, Sabadell, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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.

    (ASEBIR criteria

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

  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.

    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).

    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).

    before and after the treatment with semaglutide

  21. 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

  22. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Rodríguez, MSc

CONTACT

[email protected]

0034932274700 ext. 22029

Nikolaos P Polyzos, MD, PhD

CONTACT

[email protected]

0034932274700

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

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

Acronym: SEQ

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.