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Embryo QUAlity in Ovarian Stimulation With hMG. (EQUAM)

1 luglio 2026 aggiornato da: Fundacion Dexeus

The Impact of Ovarian Stimulation With hMG on Embryo Quality in Advanced Age Women. A Randomized Controlled Trial

Ovarian stimulation (OS) is a key component of IVF, aimed at increasing oocyte yield and improving embryo development potential. While early protocols relied solely on FSH, newer approaches incorporate hMG and LH-based stimulation, allowing more individualized treatments for specific patient populations. Evidence suggests that hMG and recombinant FSH (rFSH) have comparable effectiveness in stimulation outcomes, and current guidelines support the use of both. However, the impact of different gonadotropins on embryo quality remains unclear, with mixed findings across protocols. Given the increasing use of combined rFSH and hMG and the limited data in PPOS protocols, this study proposes a randomized controlled trial to compare embryo quality between two different rFSH-hMG dosing strategies.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Ignacio Rodriguez, MSc
  • Numero di telefono: 22029 0034932274700
  • Email: nacrod@dexeus.com

Luoghi di studio

  • Spagna
      • Barcelona, Spagna, 08037
        • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
        • Contatto:
          • Ignacio Rodríguez, BsC
          • Numero di telefono: 22029 0034932274700
          • Email: nacrod@dexeus.com
        • Investigatore principale:
          • Nikolaos P Polyzos, MD PhD
        • Sub-investigatore:
          • Valeria Donno, MD
        • Sub-investigatore:
          • Marta Plancha,, MD
      • Tarragona, Spagna, 43206
        • Dexeus Mujer Tarragona
        • Contatto:
          • Josep Gonzalo, MD
        • Sub-investigatore:
          • Josep Gonzalo, MD
    • Barcelona
      • Sabadell, Barcelona, Spagna, 08203
        • Dexeus Mujer Sabadell
        • Contatto:
        • Sub-investigatore:
          • Ainhoa Coco, MD
      • Sant Cugat del Vallès, Barcelona, Spagna, 08195
        • Dexeus Mujer Sant Cugat
        • Contatto:
        • Sub-investigatore:
          • Ainhoa Coco, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Undergoing preimplantation genetic screening cycles
  • AMH 0.5 - 3.5 ng/ml or AFC 5-20 (results of up to one year will be valid)
  • BMI 18.5 - 30 Kg/m2
  • Normal karyotypes in both partners

Exclusion Criteria:

  • Previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol), according to Bologna criteria
  • Severe male factor requiring TESE (testicular sperm extraction)
  • Administration of any other drug potentially interfering with the treatment
  • Contraindication for hormonal treatment
  • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment)
  • Monogenic disease to be detected with PGT-M
  • Biochemical and/or ultrasonographic evidence of polycystic ovarian syndrome
  • Endocrinological and/or autoimmune disorders

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 10 mcg of Rekovelle + 150 IU of Menopur
On day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Droga: 10 mcg of follitropin-delta + 150 of hMG
On day 2 or 3 of the menstrual cycle, daily injections of 10 mcg of Rekovelle + 150 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Comparatore attivo: 5 mcg of Rekovelle + 225 IU of Menopur
On day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.
Droga: 5 mcg of follitropin-delta + 225 of hMG
On day 2 or 3 of the menstrual cycle, daily injections of 5 mcg of Rekovelle + 225 IU of Menopur (Stimulation Day 1) will be administered. Scan controls and blood exams will be performed on stimulation days 6, 8 and on trigger day. Further blood exams will add according to clinical needs. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Good quality blastocysts
Lasso di tempo: From Day 5 to Day 7 after insemination
number of good quality blastocysts based on the Istanbul consensus workshop criteria
From Day 5 to Day 7 after insemination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Gonadotropin Dose Administered
Lasso di tempo: From initiation of ovarian stimulation until day of trigger (up to 15 days)
Cumulative dose of gonadotropins (IU) administered during ovarian stimulation.
From initiation of ovarian stimulation until day of trigger (up to 15 days)
Duration of Ovarian Stimulation
Lasso di tempo: From first day of stimulation until trigger day (up to 15days)
Number of days of gonadotropin administration required to reach criteria for triggering final oocyte maturation.
From first day of stimulation until trigger day (up to 15days)
Total Number of Oocytes Retrieved
Lasso di tempo: At oocyte retrieval
Total number of oocytes collected during oocyte retrieval procedure following ovarian stimulation.
At oocyte retrieval
Number of mature oocytes (MII) retrieved
Lasso di tempo: At oocyte retrieval
Number of metaphase II (MII) oocytes identified among retrieved oocytes
At oocyte retrieval
Serum levels of estradiol (E2)
Lasso di tempo: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of estradiol (E2) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of progesterone (P4)
Lasso di tempo: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels progesterone (P4) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of follicle-stimulating hormone (FSH)
Lasso di tempo: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels follicle-stimulating hormone (FSH) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels of luteinizing hormone (LH)
Lasso di tempo: At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Serum levels luteinizing hormone (LH) measured at predefined time points during stimulation
At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)
Follicle-to-Oocyte Index (FOI)
Lasso di tempo: From baseline AFC assessment to oocyte retrieval
Ratio between the total number of oocytes retrieved and the number of antral follicles counted at baseline before stimulation.
From baseline AFC assessment to oocyte retrieval
Follicular Output RaTe (FORT)
Lasso di tempo: From baseline AFC assessment to trigger day
Ratio between the number of preovulatory follicles on the day of trigger and the number of antral follicles at baseline.
From baseline AFC assessment to trigger day
Cycle cancellation rate
Lasso di tempo: From start of stimulation to planned oocyte retrieval
Proportion of initiated ovarian stimulation cycles that are cancelled before oocyte retrieval.
From start of stimulation to planned oocyte retrieval
Reason for cycle cancellation
Lasso di tempo: At time of cycle cancellation
Categorization of causes leading to cycle cancellation (e.g., poor response, hyper-response/risk of OHSS, premature ovulation, patient decision, or medical reasons).
At time of cycle cancellation
Fertilization Rate
Lasso di tempo: Assessed 16-20 hours post-insemination or ICSI
Proportion of oocytes that are successfully fertilized (2PN) relative to the number of inseminated or injected (ICSI) oocytes.
Assessed 16-20 hours post-insemination or ICSI
Time of appearance of the 2nd polar body (tPB2)
Lasso di tempo: Within 0-6 hours post-ICSI/insemination
ime from insemination or ICSI to the extrusion of the second polar body, indicating completion of oocyte activation.
Within 0-6 hours post-ICSI/insemination
Time of pronuclei appearance (tPNa)
Lasso di tempo: Within 0-20 hours post-ICSI/insemination
Time from insemination or ICSI to the first visualization of pronuclei.
Within 0-20 hours post-ICSI/insemination
Evaluation of both pronuclei
Lasso di tempo: Within 0-20 hours post-ICSI/insemination
Time from insemination or ICSI to the visualization of both pronuclei.
Within 0-20 hours post-ICSI/insemination
Time to Pronuclear Fading (tPNf)
Lasso di tempo: Within 20-30 hours post-ICSI/insemination
Time from insemination or ICSI to disappearance of pronuclei
Within 20-30 hours post-ICSI/insemination
Timing of Early Cleavage Stages (t2-t8)
Lasso di tempo: From fertilization to Day 3 (up to 72 hours)
Time to reach each embryonic cell stage from 2 to 8 cells
From fertilization to Day 3 (up to 72 hours)
Time of compaction (tSC)
Lasso di tempo: Day 3-4 post-fertilization (up to ~96 hours)
Time from fertilization to the beginning of blastomere compaction.
Day 3-4 post-fertilization (up to ~96 hours)
Time of morula (tM)
Lasso di tempo: Day 4 post-fertilization (up to 120 hours)
Time from fertilization to the formation of a compact morula stage embryo.
Day 4 post-fertilization (up to 120 hours)
Time of cavitation (tSB)
Lasso di tempo: Day 4-5 post-fertilization (up to ~120-132 hours)
Time from fertilization to the initiation of blastocoel cavity formation.
Day 4-5 post-fertilization (up to ~120-132 hours)
Time of full blastulation (tB)
Lasso di tempo: Day 5-6 post-fertilization (up to ~144 hours)
Time from fertilization to formation of a fully expanded blastocyst.
Day 5-6 post-fertilization (up to ~144 hours)
Total number of Day 5 blastocysts
Lasso di tempo: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 5 of development.
Day 5 post-fertilization
Total number of Day 6 blastocysts
Lasso di tempo: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 6 of development.
Day 5 post-fertilization
Total number of Day 7 blastocysts
Lasso di tempo: Day 5 post-fertilization
Number of embryos reaching the blastocyst stage by Day 7 of development.
Day 5 post-fertilization
Total number of euploid embryos
Lasso di tempo: After genetic testing results (typically within 1-2 weeks post-biopsy)
Number of embryos identified as chromosomally normal following preimplantation genetic testing (PGT-A)
After genetic testing results (typically within 1-2 weeks post-biopsy)
MII to blastocyst formation rate
Lasso di tempo: From oocyte retrieval to blastocyst stage (up to Day 5-7)
Proportion of mature (MII) oocytes that develop into blastocysts.
From oocyte retrieval to blastocyst stage (up to Day 5-7)
Number of embryos cryopreserved
Lasso di tempo: At end of embryo culture (Day 5-7)
Total number of embryos suitable for vitrification following culture.
At end of embryo culture (Day 5-7)
Clinical pregnancy rate
Lasso di tempo: At 5-7 weeks of gestation
Presence of one or more intrauterine gestational sacs confirmed by ultrasound.
At 5-7 weeks of gestation
Ongoing Pregnancy Rate
Lasso di tempo: At 8-10 weeks of gestation
Proportion of pregnancies with a viable intrauterine fetus beyond 8-10 weeks of gestation confirmed by ultrasound.
At 8-10 weeks of gestation
Miscarriage Rate
Lasso di tempo: From confirmation of clinical pregnancy up to 20 weeks of gestation
Proportion of clinical pregnancies that result in spontaneous pregnancy loss before 20 weeks of gestation.
From confirmation of clinical pregnancy up to 20 weeks of gestation
Live birth rate
Lasso di tempo: At delivery (up to ~40 weeks of gestation following embryo transfer)
Proportion of embryo transfer cycles resulting in at least one live-born infant, defined as the delivery of a living neonate after ≥24 weeks of gestation.
At delivery (up to ~40 weeks of gestation following embryo transfer)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fundacion Dexeus

Collaboratori

Ferring Pharmaceuticals

Investigatori

  • Investigatore principale: Nikolaos P Polyzos, MD, PhD, Dexeus Universitary Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 febbraio 2029

Completamento dello studio (Stimato)

1 maggio 2029

Date di iscrizione allo studio

Primo inviato

1 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2026

Primo Inserito (Effettivo)

8 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FSD-QUA-2025-27
  • 2025-524761-25-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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