NCT07242534

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
12mo left

Started Jan 2026

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jan 2026May 2027

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

November 17, 2025

Last Update Submit

January 19, 2026

Conditions

InfertilityObesity

Keywords

ObesityOverweightGLP-1 receptor agonistIVFART

Outcome Measures

Primary Outcomes (1)

  • Number of good quality blastocysts (GQB)

    (ASEBIR criteria

    Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage.

Secondary Outcomes (22)

  • Days of stimulation

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

  • Total dose of Gonadotropins

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

  • Number COCs

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

  • Number MII

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

  • Fertilization rate

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

  • +17 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Drug: Semaglutide

No pre-treatment

ACTIVE COMPARATOR

No pre-treatment prior to ovarian stimulation Pre-treatment

Other: No pre-treatment

Interventions

SemaglutideDRUG

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.

Semaglutide
No pre-treatmentOTHER

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.

No pre-treatment

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dexeus Mujer Sabadell

Sabadell, Barcelona, Spain

NOT YET RECRUITING

Dexeus Mujer Sant Cugat

Sant Cugat del Vallès, Barcelona, 08195, Spain

NOT YET RECRUITING

Dexeus Mujer Reus

Reus, Tarragona, 43202, Spain

NOT YET RECRUITING

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08028, Spain

RECRUITING

Dexeus Mujer Tarragona

Tarragona, 43206, Spain

NOT YET RECRUITING

Related Publications (19)

  • 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: 33257906BACKGROUND

  • 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: 38444070BACKGROUND

  • 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: 26097395BACKGROUND

  • 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: 36635080BACKGROUND

  • 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: 38810863BACKGROUND

  • 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: 30910544BACKGROUND

  • 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: 31260047BACKGROUND

  • 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: 36551163BACKGROUND

  • 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: 30763543BACKGROUND

  • 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: 21806596BACKGROUND

  • 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: 37427372BACKGROUND

  • 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.

    PMID: 38339186BACKGROUND

  • Sacha CR, Page CM, Goldman RH, Ginsburg ES, Zera CA. Are women with obesity and infertility willing to attempt weight loss prior to fertility treatment? Obes Res Clin Pract. 2018 Jan-Feb;12(1):125-128. doi: 10.1016/j.orcp.2017.11.004. Epub 2017 Dec 6.

    PMID: 29221938BACKGROUND

  • Salamun V, Jensterle M, Janez A, Vrtacnik Bokal E. Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study. Eur J Endocrinol. 2018 Jul;179(1):1-11. doi: 10.1530/EJE-18-0175. Epub 2018 Apr 27.

    PMID: 29703793BACKGROUND

  • Silvestris E, de Pergola G, Rosania R, Loverro G. Obesity as disruptor of the female fertility. Reprod Biol Endocrinol. 2018 Mar 9;16(1):22. doi: 10.1186/s12958-018-0336-z.

    PMID: 29523133BACKGROUND

  • Szczesnowicz A, Szeliga A, Niwczyk O, Bala G, Meczekalski B. Do GLP-1 Analogs Have a Place in the Treatment of PCOS? New Insights and Promising Therapies. J Clin Med. 2023 Sep 12;12(18):5915. doi: 10.3390/jcm12185915.

    PMID: 37762856BACKGROUND

  • Sola-Leyva A, Pathare ADS, Apostolov A, Aleksejeva E, Kask K, Tammiste T, Ruiz-Duran S, Risal S, Acharya G, Salumets A. The hidden impact of GLP-1 receptor agonists on endometrial receptivity and implantation. Acta Obstet Gynecol Scand. 2025 Feb;104(2):258-266. doi: 10.1111/aogs.15010. Epub 2024 Dec 18.

    PMID: 39696822BACKGROUND

  • Sundararaman L, Gouda D, Kumar A, Sundararaman S, Goudra B. Glucagon-like Peptide-1 Receptor Agonists: Exciting Avenues Beyond Weight Loss. J Clin Med. 2025 Mar 14;14(6):1978. doi: 10.3390/jcm14061978.

    PMID: 40142784BACKGROUND

  • Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

    PMID: 33567185BACKGROUND

Related Links

MeSH Terms

Conditions

InfertilityObesityOverweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nikolaos P Polyzos, MD, PhD

    Dexeus Fertility

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaos P Polyzos, MD, PhD

CONTACT

0034932274700nikpol@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700nacrod@dexeus.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

January 19, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

ES(5)