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NCT07242534·Phase 4·INTERVENTIONAL

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

TriptorelinWeight lossRecruiting

Status

Recruiting

Phase

Phase 4

Enrollment

62

Locations

5

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Nov 21, 2025

  2. Study start

    Jan 19, 2026

  3. Primary completion

    Feb 2027

  4. Study completion

    May 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jan 21, 2026

Outcomes

What the study measures.

Primary outcomes

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

Days of stimulation

Time frame · 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).

Number COCs

Time frame · 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

Fertilization rate

Time frame · 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).

Time of pronuclei appearance (tPNa)

Time frame · 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.

Time of pronuclei disappearance (tPNf)

Time frame · 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
38 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

5 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Dexeus Mujer Sabadell

Sabadell, Barcelona, Spain

Dexeus Mujer Sant Cugat

Sant Cugat del Vallès, Barcelona, Spain

Dexeus Mujer Reus

Reus, Tarragona, Spain

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, Spain

Dexeus Mujer Tarragona

Tarragona, Spain

Publications

Results and literature.

PMID 33257906 ↗Amiri M, Ramezani Tehrani F. Potential Adverse Effects of Female and Male Obesity on Fertility: A Narrative Review. Int J Endocrinol Metab. 2020 Sep 28;18(3):e101776. doi: 10.5812/ijem.101776. eCollection 2020 Jul.PMID 38444070 ↗Bader S, Bhatti R, Mussa B, Abusanana S. A systematic review of GLP-1 on anthropometrics, metabolic and endocrine parameters in patients with PCOS. Womens Health (Lond). 2024 Jan-Dec;20:17455057241234530. doi: 10.1177/17455057241234530.PMID 26097395 ↗Dag ZO, Dilbaz B. Impact of obesity on infertility in women. J Turk Ger Gynecol Assoc. 2015 Jun 1;16(2):111-7. doi: 10.5152/jtgga.2015.15232. eCollection 2015.PMID 36635080 ↗Gautam D, Purandare N, Maxwell CV, Rosser ML, O'Brien P, Mocanu E, McKeown C, Malhotra J, McAuliffe FM; FIGO Committee on Impact of Pregnancy on Long-term Health and the FIGO Committee on Reproductive Medicine, Endocrinology and Infertility. The challenges of obesity for fertility: A FIGO literature review. Int J Gynaecol Obstet. 2023 Jan;160 Suppl 1(Suppl 1):50-55. doi: 10.1002/ijgo.14538.PMID 38810863 ↗Goldberg AS, Boots CE. Treating obesity and fertility in the era of glucagon-like peptide 1 receptor agonists. Fertil Steril. 2024 Aug;122(2):211-218. doi: 10.1016/j.fertnstert.2024.05.154. Epub 2024 May 27.PMID 30910544 ↗He Y, Lu Y, Zhu Q, Wang Y, Lindheim SR, Qi J, Li X, Ding Y, Shi Y, Wei D, Chen ZJ, Sun Y. Influence of metabolic syndrome on female fertility and in vitro fertilization outcomes in PCOS women. Am J Obstet Gynecol. 2019 Aug;221(2):138.e1-138.e12. doi: 10.1016/j.ajog.2019.03.011. Epub 2019 Mar 22.PMID 31260047 ↗Jensterle M, Janez A, Fliers E, DeVries JH, Vrtacnik-Bokal E, Siegelaar SE. The role of glucagon-like peptide-1 in reproduction: from physiology to therapeutic perspective. Hum Reprod Update. 2019 Jul 1;25(4):504-517. doi: 10.1093/humupd/dmz019.PMID 36551163 ↗Khan D, Ojo OO, Woodward OR, Lewis JE, Sridhar A, Gribble FM, Reimann F, Flatt PR, Moffett RC. Evidence for Involvement of GIP and GLP-1 Receptors and the Gut-Gonadal Axis in Regulating Female Reproductive Function in Mice. Biomolecules. 2022 Nov 23;12(12):1736. doi: 10.3390/biom12121736.PMID 30763543 ↗Li MC, Minguez-Alarcon L, Arvizu M, Chiu YH, Ford JB, Williams PL, Attaman J, Hauser R, Chavarro JE; EARTH Study Team. Waist circumference in relation to outcomes of infertility treatment with assisted reproductive technologies. Am J Obstet Gynecol. 2019 Jun;220(6):578.e1-578.e13. doi: 10.1016/j.ajog.2019.02.013. Epub 2019 Feb 11.PMID 21806596 ↗Moran L, Tsagareli V, Norman R, Noakes M. Diet and IVF pilot study: short-term weight loss improves pregnancy rates in overweight/obese women undertaking IVF. Aust N Z J Obstet Gynaecol. 2011 Oct;51(5):455-9. doi: 10.1111/j.1479-828X.2011.01343.x. Epub 2011 Jul 19.PMID 37427372 ↗Nuako A, Tu L, Reyes KJC, Chhabria SM, Stanford FC. Pharmacologic Treatment of Obesity in Reproductive Aged Women. Curr Obstet Gynecol Rep. 2023 Jun;12(2):138-146. doi: 10.1007/s13669-023-00350-1. Epub 2023 Feb 27.PMID 38339186 ↗Pavli P, Triantafyllidou O, Kapantais E, Vlahos NF, Valsamakis G. Infertility Improvement after Medical Weight Loss in Women and Men: A Review of the Literature. Int J Mol Sci. 2024 Feb 5;25(3):1909. doi: 10.3390/ijms25031909.

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