Embryo QUAlity in Ovarian Stimulation With hMG.
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.
Timeline
- Start
- 2026-09
- Primary completion
- 2029-02
- Completion
- 2029-05
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Follitropin delta | Protein / enzyme biologic | 5 ug | — |
| Comparator | Follitropin delta | Protein / enzyme biologic | 10 ug | — |
| Subject | hMG | Unknown | 150 iu | — |
| Comparator | hMG | Unknown | 150 iu | — |
| Subject | hMG | Unknown | 225 iu | — |
| Comparator | hMG | Unknown | 225 iu | — |