InfertilityPhase 4SEQNCT07242534
Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization.
A Phase 4 study testing Semaglutide and No pre-treatment in people with Infertility and Obesity, run by Fundacion Dexeus at 5 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Obesity
- What is being tested?
- Semaglutide and No pre-treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesSpain
- Study dates
- 19 Jan 2026to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ≤ 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
Who cannot join
- 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
Show all 10Show fewer
- Family history of hereditary or chromosomal diseases
- Use of glucocorticoids or immunosuppressants
- PGT-A
- Use of medications affecting metabolism or inflammation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, 08028
Ignacio Rodríguez, MSc, 0034932274700 ext. 22029, nacrod@dexeus.com
Valeria Donno, MD
- Not yet recruiting
Dexeus Mujer Reus
Reus, Tarragona, 43202
Josep Gonzalo, MD, JOSGON@dexeus.com
Josep Gonzalo, MD
- Not yet recruiting
Dexeus Mujer Sabadell
Sabadell, Barcelona
Ainhoa Coco, MD, 0034932274700, aincoc@dexeus.com
Ainhoa Coco, MD
- Not yet recruiting
Dexeus Mujer Sant Cugat
Sant Cugat del Vallès, Barcelona, 08195
Ainhoa Coco, MD, 0034932274700, aincoc@dexeus.com
Ainhoa Coco, MD
- Not yet recruiting
Dexeus Mujer Tarragona
Tarragona, 43206
Josep Gonzalo, MD, josgon@dexeus.com
Josep Gonzalo, MD
About this study
Official title: Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization. A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Infertility, Obesity
- Being tested
- Semaglutide, No pre-treatment
- Keywords
- Obesity, Overweight, GLP-1 receptor agonist, IVF, ART
- Medical subject headings
- Infertility, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Semaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation Receives: Drug: Semaglutide |
| No pre-treatment | Active comparator | No pre-treatment prior to ovarian stimulation Pre-treatment Receives: Other: No pre-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of good quality blastocysts (GQB)
(ASEBIR criteria
Measured: 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
Measured: From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant.
Total dose of Gonadotropins
Measured: From first day of ovarian stimulation to trigger day (8-12 days total).
Number COCs
Measured: Assessed on day of oocyte retrieval, approx. 34-36 hours after ovulation trigger.
Number MII
Measured: Assessed on same day as oocyte retrieval, after denudation and classification
Fertilization rate
Measured: Assessed on Day 1 after ICSI, 16-18 hours post-injection
Time of appearance of the 2nd polar body (tPB2)
Measured: Recorded via time-lapse system, within first 8 hours post-ICSI (Day 0).
Time of pronuclei appearance (tPNa)
Measured: Measured on Day 1 post-ICSI using time-lapse monitoring.
Evaluation of both pronuclei (PN)
Measured: Assessed during pronuclear stage on Day 1 post-ICSI.
Time of pronuclei disappearance (tPNf)
Measured: Recorded by time-lapse imaging, approx. 20-24 hours post-ICSI.
Time of division from 2 to 8 cells
Measured: Tracked continuously via time-lapse, from Day 2 to Day 3 post-ICSI
Time of compaction (tSC)
Measured: Tracked by time-lapse imaging on Day 4 post-ICSI
Time of morula (tM)
Measured: Recorded by time-lapse on Day 4 post-ICSI.
Time of cavitation (tSB)
Measured: Recorded by time-lapse on Day 5 post-ICSI.
Time of full blastulation (tB)
Measured: Measured by time-lapse on Day 5 of embryo culture
Total number of day 5 blastocysts
Measured: Counted on Day 5 of embryo culture after ICSI
Blastocyst formation rate,
the proportion of 2PN zygotes that reach the blastocyst stage
Measured: Calculated on Day 5 based on 2PN embryos reaching blastocyst stage.
Number of embryos cryopreserved
Measured: Recorded at time of freezing on Day 5-7 of embryo culture
Embryo stage (D5, D6, D7)
Measured: Assessed at time of embryo cryopreservation on Day 5 to 7
Change in AFC
before and after the treatment with semaglutide
Measured: Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
Change in AMH
before and after the treatment with semaglutide
Measured: Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
Change in BMI
before and after the treatment with semaglutide
Measured: : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).
Change in WC
before and after the treatment with semaglutide
Measured: : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start19 Jan 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos P Polyzos, MD, PhD, Principal investigator, Dexeus Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242534
- Sponsor's protocol ID
- FSD-SEM-2025-14
- Other IDs
- 2025-522525-34-00, 2025
- Acronym
- SEQ
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33257906Bader 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.
PubMed 38444070Dag 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.
PubMed 26097395Gautam 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.
PubMed 36635080Goldberg 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.
PubMed 38810863He 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.
PubMed 30910544Jensterle 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.
PubMed 31260047Khan 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.
PubMed 36551163Li 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.
PubMed 30763543Moran 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.
PubMed 21806596Nuako 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.
PubMed 37427372Pavli 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.
PubMed 38339186Sacha 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.
PubMed 29221938Salamun 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.
PubMed 29703793Silvestris 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.
PubMed 29523133
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07242534
- Acronym / sponsor ID
- SEQ / FSD-SEM-2025-14
- Conditions
- Infertility, Obesity
- Keywords
- Obesity, Overweight, GLP-1 receptor agonist, IVF, ART
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideSemaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation |
| No pre-treatment | Active comparator | Other: No pre-treatmentNo pre-treatment prior to ovarian stimulation Pre-treatment |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ≤ 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideParticipants 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. | Drug | Semaglutide |
| No pre-treatmentParticipants 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. | Other | No pre-treatment |
Primary outcome
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
22 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
Time of compaction (tSC)
Time frame: Tracked by time-lapse imaging on Day 4 post-ICSI
Time of morula (tM)
Time frame: Recorded by time-lapse on Day 4 post-ICSI.
Time of cavitation (tSB)
Time frame: Recorded by time-lapse on Day 5 post-ICSI.
Time of full blastulation (tB)
Time frame: Measured by time-lapse on Day 5 of embryo culture
Total number of day 5 blastocysts
Time frame: Counted on Day 5 of embryo culture after ICSI
Blastocyst formation rate,
Time frame: Calculated on Day 5 based on 2PN embryos reaching blastocyst stage.
Number of embryos cryopreserved
Time frame: Recorded at time of freezing on Day 5-7 of embryo culture
Embryo stage (D5, D6, D7)
Time frame: Assessed at time of embryo cryopreservation on Day 5 to 7
Change in AFC
Time frame: Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
Change in AMH
Time frame: Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).
Change in BMI
Time frame: : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).
Change in WC
Time frame: : Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 33257906Amiri 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.
- Background: PubMed 38444070Bader 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.
- Background: PubMed 26097395Dag 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.
- Background: PubMed 36635080Gautam 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.
- Background: PubMed 38810863Goldberg 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.
- Background: PubMed 30910544He 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.
- Background: PubMed 31260047Jensterle 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.
- Background: PubMed 36551163Khan 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.
- Background: PubMed 30763543Li 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.
- Background: PubMed 21806596Moran 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.
- Background: PubMed 37427372Nuako 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.
- Background: PubMed 38339186Pavli 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolaos P Polyzos, MD, PhD principal investigator
Dexeus Fertility
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide and No pre-treatment in people with Infertility and Obesity, run by Fundacion Dexeus at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos P Polyzos, MD, PhD (0034932274700, nikpol@dexeus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07242534, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.