Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
62
Countries
1
Sites
5
Infertility
To evaluate if a pre-treatment with Semaglutide during 12 weeks (group A) versus no pre-treatment (Group B) could affect the number of good quality blastocysts in overweight and obese patients undergoing IVF cycles.
Key facts
- Sponsor
- Santiago Dexeus Font Fundacio Privada
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 19 Jan 2026 → ongoing
- Decision date (initial)
- 2025-10-24
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fundación Santiago Dexeus Font
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate if a pre-treatment with Semaglutide during 12 weeks (group A) versus no pre-treatment (Group B) could affect the number of good quality blastocysts in overweight and obese patients undergoing IVF cycles.
Secondary objectives 21
- Days of stimulation
- Total dose of Gonadotropins
- Number cumulus-oocyte complex (COCs)
- Number MII
- Fertilization rate
- Time of appearance of the 2nd polar body (tPB2)
- Time of pronuclei appearance (tPNa)
- Evaluation of both pronuclei (PN)
- Time of pronuclei disappearance (tPNf)
- Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)
- Time of compaction (tSC)
- Time of morula (tM)
- Time of cavitation (tSB)
- Time of full blastulation (tB)
- Total number of day 5 blastocysts
- Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage
- Number of embryos cryopreserved
- Embryo stage (D5, D6, D7)
- Ovarian reserve markers (AFC, AMH) before and after the treatment with semaglutide
- Change in body weight and BMI, before and after the treatment with semaglutide
- Change in WC, before and after the treatment with semaglutide
Conditions and MedDRA coding
Infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≤ 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 10
- 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
- Preimplantation Genetic Testing for Aneuploidy (PGT-A)
- Use of medications affecting metabolism or inflammation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of good quality blastocysts
Secondary endpoints 21
- Days of stimulation
- Total dose of Gonadotropins
- Number Cumulus-oocyte complex (COCs)
- Number MII
- Fertilization rate
- Time of appearance of the 2nd polar body (tPB2)
- Time of pronuclei appearance (tPNa)
- Evaluation of both pronuclei (PN)
- Time of pronuclei disappearance (tPNf)
- Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)
- Time of compaction (tSC)
- Time of morula (tM)
- Time of cavitation (tSB)
- Time of full blastulation (tB)
- Total number of day 5 blastocysts
- Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage
- Number of embryos cryopreserved
- Embryo stage (D5, D6, D7)
- Ovarian reserve markers (Antral Follicle Count,(AFC), Antimullerian Hormone (AMH)) before and after the treatment with semaglutide
- Change in body weight and BMI, before and after the treatment with semaglutide
- Change in WC, before and after the treatment with semaglutide
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Wegovy 1 mg solution for injection in pre-filled pen
PRD9446837 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/003
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
PRD4656315 · Product
- Active substance
- Follitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 4500 IU international unit(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/909/004
- MA holder
- GEDEON RICHTER PLC.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in pre-filled syringe
PRD10985567 · Product
- Active substance
- Ganirelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCONJUNCTIVAL USE
- Max daily dose
- 0.25 mg milligram(s)
- Max total dose
- 1.75 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01CC01 — GANIRELIX
- Marketing authorisation
- EU/1/22/1658/003
- MA holder
- GEDEON RICHTER PLC.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
PRD390680 · Product
- Active substance
- Triptorelin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.2 mg milligram(s)
- Max total dose
- 0.2 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- 62.431
- MA holder
- IPSEN PHARMA S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Santiago Dexeus Font Fundacio Privada
- Sponsor organisation
- Santiago Dexeus Font Fundacio Privada
- Address
- Gran Via De Carles III 71-75
- City
- Barcelona
- Postcode
- 08028
- Country
- Spain
Scientific contact point
- Organisation
- Santiago Dexeus Font Fundacio Privada
- Contact name
- Research Unit
Public contact point
- Organisation
- Santiago Dexeus Font Fundacio Privada
- Contact name
- Research Unit
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 62 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Quironsalud Del Valles
Department of Reproductive Medicine, Passeig Rubio I Ors 25-27, 08203, Sabadell
Hospital Universitari General De Catalunya
Department of Reproductive Medicine, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Dexeus Mujer Reus
Department of Reproductive Medicine, Pg de Prim, 2, Reus Tarragona
Hospital Universitari Dexeus Grupo Quironsalud
Department of Reproductive Medicine, Calle De Sabino Arana 5-19, 08028, Barcelona
Dexeus Mujer Tarragona
Department of Reproductive Medicine, Av. Josep Maria Recasens, SN, Tarragona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-01-19 | 2026-01-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_SEQ | 1 |
| Recruitment arrangements (for publication) | Adv_Copy out | 1 |
| Recruitment arrangements (for publication) | Adv_Mail_Pacientes SEQ | 1 |
| Recruitment arrangements (for publication) | Adv_Mail_Pacientes SEQ_CA | 1 |
| Recruitment arrangements (for publication) | Adv_Pagina_web_SEQ | 1 |
| Recruitment arrangements (for publication) | Adv_Pagina_web_SEQ_CA | 1 |
| Recruitment arrangements (for publication) | Adv_Reel SocialMedia Link | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ HIPCI_SEQ | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | FT_wegovy | 1 |
| Synopsis of the protocol (for publication) | D1_Summary SEQ_EN | 1 |
| Synopsis of the protocol (for publication) | D1_Summary SEQ_ES | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-28 | Spain | Acceptable 2025-09-18
|
2025-10-24 |