SEQ

RecruitingPhase 4

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

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

Lead sponsor

Fundacion Dexeus

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Reproductive / infertility

Key I/E criteria

•BMI 27-40•Female

Primary endpoint

•Number of good quality blastocysts (GQB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07242534

Org study IDFSD-SEM-2025-14

Secondary ID2025-522525-34-00

Timeline

Milestones

Study first posted2025-11-21actual

Study start2026-01-19actual

Last update posted2026-01-21actual

Primary completion2027-02estimated (month precision)

Study completion2027-05estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightReproductive / infertility

Eligibility

Who can enroll

Minimum age18 Years

Maximum age38 Years

SexFemale

Healthy volunteersNot accepted

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

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Weight & body composition

Other (unclassified)

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in BMI

Time frame:: Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in WC

Time frame:: Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).

Waist circumference, change

change from baseline, improvement

Other clinical outcomes

20 endpoints

Primary/protocol endpoint/low confidence

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.

descriptive

Secondary/protocol endpoint

Days of stimulation

Time frame:From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant.

descriptive

Secondary/protocol endpoint

Total dose of Gonadotropins

Time frame:From first day of ovarian stimulation to trigger day (8-12 days total).

descriptive

Secondary/protocol endpoint

Number COCs

Time frame:Assessed on day of oocyte retrieval, approx. 34-36 hours after ovulation trigger.

descriptive

Secondary/protocol endpoint

Number MII

Time frame:Assessed on same day as oocyte retrieval, after denudation and classification

event count, descriptive

Secondary/protocol endpoint

Fertilization rate

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

descriptive

Secondary/protocol endpoint/low confidence

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

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

descriptive

Secondary/protocol endpoint/low confidence

Time of pronuclei appearance (tPNa)

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

descriptive

Secondary/protocol endpoint/low confidence

Evaluation of both pronuclei (PN)

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

categorical status, descriptive

Secondary/protocol endpoint/low confidence

Time of pronuclei disappearance (tPNf)

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

descriptive

Secondary/protocol endpoint

Time of division from 2 to 8 cells

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

descriptive

Secondary/protocol endpoint/low confidence

Time of compaction (tSC)

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

descriptive

Secondary/protocol endpoint/low confidence

Time of morula (tM)

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

descriptive

Secondary/protocol endpoint/low confidence

Time of cavitation (tSB)

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

descriptive

Secondary/protocol endpoint/low confidence

Time of full blastulation (tB)

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

descriptive

Secondary/protocol endpoint

Total number of day 5 blastocysts

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

event count, descriptive

Secondary/protocol endpoint/low confidence

Blastocyst formation rate,

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

ratio, improvement

Secondary/protocol endpoint

Number of embryos cryopreserved

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

event count, descriptive

Secondary/protocol endpoint/low confidence

Embryo stage (D5, D6, D7)

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

categorical status, descriptive

Secondary/protocol endpoint

Change in AMH

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

change from baseline, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in AFC

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

change from baseline, descriptive

Publications (19)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glucagon-like Peptide-1 Receptor Agonists: Exciting Avenues Beyond Weight Loss.
Journal of clinical medicine2025 Mar 14PMID40142784doi:10.3390/jcm14061978via CT.gov background
The hidden impact of GLP-1 receptor agonists on endometrial receptivity and implantation.
Acta obstetricia et gynecologica Scandinavica2025 Feb (month)PMID39696822doi:10.1111/aogs.15010via CT.gov background
Treating obesity and fertility in the era of glucagon-like peptide 1 receptor agonists.
Fertility and sterility2024 Aug (month)PMID38810863doi:10.1016/j.fertnstert.2024.05.154via CT.gov background
Infertility Improvement after Medical Weight Loss in Women and Men: A Review of the Literature.
International journal of molecular sciences2024 Feb 5PMID38339186doi:10.3390/ijms25031909via CT.gov background
A systematic review of GLP-1 on anthropometrics, metabolic and endocrine parameters in patients with PCOS.
Women's health (London, England)2024 Jan-Dec (year)PMID38444070doi:10.1177/17455057241234530via CT.gov background
Do GLP-1 Analogs Have a Place in the Treatment of PCOS? New Insights and Promising Therapies.
Journal of clinical medicine2023 Sep 12PMID37762856doi:10.3390/jcm12185915via CT.gov background
Pharmacologic Treatment of Obesity in Reproductive Aged Women.
Current obstetrics and gynecology reports2023 Jun (month)PMID37427372doi:10.1007/s13669-023-00350-1via CT.gov background
The challenges of obesity for fertility: A FIGO literature review.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2023 Jan (month)PMID36635080doi:10.1002/ijgo.14538via CT.gov background
Evidence for Involvement of GIP and GLP-1 Receptors and the Gut-Gonadal Axis in Regulating Female Reproductive Function in Mice.
Biomolecules2022 Nov 23PMID36551163doi:10.3390/biom12121736via CT.gov background
Once-Weekly Semaglutide in Adults with Overweight or Obesity.
The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov background
Potential Adverse Effects of Female and Male Obesity on Fertility: A Narrative Review.
International journal of endocrinology and metabolism2020 Jul (month)PMID33257906doi:10.5812/ijem.101776via CT.gov background
Influence of metabolic syndrome on female fertility and in vitro fertilization outcomes in PCOS women.
American journal of obstetrics and gynecology2019 Aug (month)PMID30910544doi:10.1016/j.ajog.2019.03.011via CT.gov background
The role of glucagon-like peptide-1 in reproduction: from physiology to therapeutic perspective.
Human reproduction update2019 Jul 1PMID31260047doi:10.1093/humupd/dmz019via CT.gov background
Waist circumference in relation to outcomes of infertility treatment with assisted reproductive technologies.
American journal of obstetrics and gynecology2019 Jun (month)PMID30763543doi:10.1016/j.ajog.2019.02.013via CT.gov background
Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study.
European journal of endocrinology2018 Jul (month)PMID29703793doi:10.1530/EJE-18-0175via CT.gov background
Obesity as disruptor of the female fertility.
Reproductive biology and endocrinology : RB&E2018 Mar 9PMID29523133doi:10.1186/s12958-018-0336-zvia CT.gov background
Are women with obesity and infertility willing to attempt weight loss prior to fertility treatment?
Obesity research & clinical practice2018 Jan-Feb (year)PMID29221938doi:10.1016/j.orcp.2017.11.004via CT.gov background
Impact of obesity on infertility in women.
Journal of the Turkish German Gynecological Association2015 (year)PMID26097395doi:10.5152/jtgga.2015.15232via CT.gov background
Diet and IVF pilot study: short-term weight loss improves pregnancy rates in overweight/obese women undertaking IVF.
The Australian & New Zealand journal of obstetrics & gynaecology2011 Oct (month)PMID21806596doi:10.1111/j.1479-828X.2011.01343.xvia CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.