Embryo QUAlity in Ovarian Stimulation With hMG.

NCT07691073 | Not Yet Recruiting Phase 4

• 2 other identifiers: FSD-QUA-2025-272025-524761-25-00
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Good quality blastocysts

  number of good quality blastocysts based on the Istanbul consensus workshop criteria

  From Day 5 to Day 7 after insemination

Secondary Outcomes (32)

• Total Gonadotropin Dose Administered

  From initiation of ovarian stimulation until day of trigger (up to 15 days)

• Duration of Ovarian Stimulation

  From first day of stimulation until trigger day (up to 15days)

• Total Number of Oocytes Retrieved

  At oocyte retrieval

• Number of mature oocytes (MII) retrieved

  At oocyte retrieval

• Serum levels of estradiol (E2)

  At baseline, mid-stimulation (e.g., Day 5-7), and trigger day (up to 5 days)

Study Arms (2)

10 mcg of Rekovelle + 150 IU of Menopur

EXPERIMENTAL

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.

Drug: 10 mcg of follitropin-delta + 150 of hMG

5 mcg of Rekovelle + 225 IU of Menopur

ACTIVE COMPARATOR

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.

Drug: 5 mcg of follitropin-delta + 225 of hMG

Interventions

10 mcg of follitropin-delta + 150 of hMG DRUG

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.

10 mcg of Rekovelle + 150 IU of Menopur

5 mcg of follitropin-delta + 225 of hMG DRUG

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.

5 mcg of Rekovelle + 225 IU of Menopur

Eligibility Criteria

• Age: 38 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Dexeus: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (4)

Dexeus Mujer Sabadell

Sabadell, Barcelona, 08203, Spain

Location

Dexeus Mujer Sant Cugat

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

Location

Dexeus Mujer Tarragona

Tarragona, 43206, Spain

Location

Related Publications (11)

• 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.

  PMID: 32163564 BACKGROUND

• 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.

  PMID: 38845190 BACKGROUND

• 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.

  PMID: 9563682 BACKGROUND

• 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.

  PMID: 32416978 BACKGROUND

• 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.

  PMID: 17640944 BACKGROUND

• 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.

  PMID: 16873892 BACKGROUND

• 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.

  PMID: 9604764 BACKGROUND

• 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.

  PMID: 33118716 BACKGROUND

• 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.

  PMID: 34154604 BACKGROUND

• 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.

  PMID: 12909504 BACKGROUND

• 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.

  PMID: 15388674 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Nikolaos P Polyzos, MD, PhD

  Dexeus Universitary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignacio Rodriguez, MSc

CONTACT

0034932274700; nacrod@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: July 1, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

ES (4)