Embryo QUAlity in Ovarian Stimulation With hMG. (EQUAM)
1. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
240
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ignacio Rodriguez, MSc
- Telefonnummer: 22029 0034932274700
- E-mail: nacrod@dexeus.com
Studiesteder
-
-
-
Barcelona, Spanien, 08037
- Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
-
Kontakt:
- Ignacio Rodríguez, BsC
- Telefonnummer: 22029 0034932274700
- E-mail: nacrod@dexeus.com
-
Ledende efterforsker:
- Nikolaos P Polyzos, MD PhD
-
Underforsker:
- Valeria Donno, MD
-
Underforsker:
- Marta Plancha,, MD
-
Tarragona, Spanien, 43206
- Dexeus Mujer Tarragona
-
Kontakt:
- Josep Gonzalo, MD
-
Underforsker:
- Josep Gonzalo, MD
-
-
Barcelona
-
Sabadell, Barcelona, Spanien, 08203
- Dexeus Mujer Sabadell
-
Kontakt:
- Ainhoa Coco, MD
- E-mail: aincoc@dexeus.com
-
Underforsker:
- Ainhoa Coco, MD
-
Sant Cugat del Vallès, Barcelona, Spanien, 08195
- Dexeus Mujer Sant Cugat
-
Kontakt:
- Ainhoa Coco, MD
- Telefonnummer: 0034932274700
- E-mail: aincoc@dexeus.com
-
Underforsker:
- Ainhoa Coco, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Good quality blastocysts
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Gonadotropin Dose Administered
Tidsramme: 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
Tidsramme: 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
Tidsramme: At oocyte retrieval
|
Total number of oocytes collected during oocyte retrieval procedure following ovarian stimulation.
|
At oocyte retrieval
|
|
Number of mature oocytes (MII) retrieved
Tidsramme: At oocyte retrieval
|
Number of metaphase II (MII) oocytes identified among retrieved oocytes
|
At oocyte retrieval
|
|
Serum levels of estradiol (E2)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nikolaos P Polyzos, MD, PhD, Dexeus Universitary Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006 Dec;21(12):3217-27. doi: 10.1093/humrep/del284. Epub 2006 Jul 27.
- Filicori M, Cognigni GE, Pocognoli P, Tabarelli C, Ferlini F, Perri T, Parmegiani L. Comparison of controlled ovarian stimulation with human menopausal gonadotropin or recombinant follicle-stimulating hormone. Fertil Steril. 2003 Aug;80(2):390-7. doi: 10.1016/s0015-0282(03)00594-6.
- Witz CA, Daftary GS, Doody KJ, Park JK, Seifu Y, Yankov VI, Heiser PW; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer - High Responder (MEGASET-HR) Trial Group. Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection. Fertil Steril. 2020 Aug;114(2):321-330. doi: 10.1016/j.fertnstert.2020.03.029. Epub 2020 May 13.
- Montoya-Botero P, Martinez F, Rodriguez-Purata J, Rodriguez I, Coroleu B, Polyzos NP. The effect of type of oral contraceptive pill and duration of use on fresh and cumulative live birth rates in IVF/ICSI cycles. Hum Reprod. 2020 Apr 28;35(4):826-836. doi: 10.1093/humrep/dez299.
- Racca A, Rodriguez I, Garcia S, Arroyo G, Polyzos NP. Double versus single stimulation in young low prognosis patients followed by a fresh embryo transfer: a randomized controlled trial (DUOSTIM-fresh). Hum Reprod. 2024 Jun 6:deae104. doi: 10.1093/humrep/deae104. Online ahead of print.
- Veiga A, Sandalinas M, Benkhalifa M, Boada M, Carrera M, Santalo J, Barri PN, Menezo Y. Laser blastocyst biopsy for preimplantation diagnosis in the human. Zygote. 1997 Nov;5(4):351-4. doi: 10.1017/s0967199400003920.
- Ziebe S, Lundin K, Janssens R, Helmgaard L, Arce JC; MERIT (Menotrophin vs Recombinant FSH in vitro Fertilisation Trial) Group. Influence of ovarian stimulation with HP-hMG or recombinant FSH on embryo quality parameters in patients undergoing IVF. Hum Reprod. 2007 Sep;22(9):2404-13. doi: 10.1093/humrep/dem221. Epub 2007 Jul 19.
- Boada M, Carrera M, De La Iglesia C, Sandalinas M, Barri PN, Veiga A. Successful use of a laser for human embryo biopsy in preimplantation genetic diagnosis: report of two cases. J Assist Reprod Genet. 1998 May;15(5):302-7. doi: 10.1023/a:1022548612107.
- Chapon RCB, Genro VK, Souza CAB, Cunha-Filho JS. Randomized controlled trial comparing embryonic quality in rFSH versus hMG in the IVF protocol with GnRH Antagonist. JBRA Assist Reprod. 2021 Feb 2;25(1):131-135. doi: 10.5935/1518-0557.20200064.
- Conforti A, Esteves SC, Humaidan P, Longobardi S, D'Hooghe T, Orvieto R, Vaiarelli A, Cimadomo D, Rienzi L, Ubaldi FM, Zullo F, Alviggi C. Recombinant human luteinizing hormone co-treatment in ovarian stimulation for assisted reproductive technology in women of advanced reproductive age: a systematic review and meta-analysis of randomized controlled trials. Reprod Biol Endocrinol. 2021 Jun 21;19(1):91. doi: 10.1186/s12958-021-00759-4.
- Lunenfeld B. Historical perspectives in gonadotrophin therapy. Hum Reprod Update. 2004 Nov-Dec;10(6):453-67. doi: 10.1093/humupd/dmh044. Epub 2004 Sep 23.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. februar 2029
Studieafslutning (Anslået)
1. maj 2029
Datoer for studieregistrering
Først indsendt
1. juli 2026
Først indsendt, der opfyldte QC-kriterier
1. juli 2026
Først opslået (Faktiske)
8. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FSD-QUA-2025-27
- 2025-524761-25-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .