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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524761-25-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Good quality blastocysts | number of good quality blastocysts based on the Istanbul consensus workshop criteria | From Day 5 to Day 7 after insemination |
| Measure | Description | Time Frame |
|---|---|---|
| Total Gonadotropin Dose Administered | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Rodriguez, MSc | Contact | 0034932274700 | 22029 | nacrod@dexeus.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos P Polyzos, MD, PhD | Dexeus Universitary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dexeus Mujer Sabadell | Sabadell | Barcelona | 08203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32163564 | 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. | |
| 38845190 | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000620228 | follitropin delta |
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| 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. |
|
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 | Total number of oocytes collected during oocyte retrieval procedure following ovarian stimulation. | At oocyte retrieval |
| Number of mature oocytes (MII) retrieved | Number of metaphase II (MII) oocytes identified among retrieved oocytes | At oocyte retrieval |
| Serum levels of estradiol (E2) | 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) | 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) | 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) | 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) | 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) | 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 | Proportion of initiated ovarian stimulation cycles that are cancelled before oocyte retrieval. | From start of stimulation to planned oocyte retrieval |
| Reason for 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 | 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) | 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) | Time from insemination or ICSI to the first visualization of pronuclei. | Within 0-20 hours post-ICSI/insemination |
| Evaluation of both pronuclei | Time from insemination or ICSI to the visualization of both pronuclei. | Within 0-20 hours post-ICSI/insemination |
| Time to Pronuclear Fading (tPNf) | Time from insemination or ICSI to disappearance of pronuclei | Within 20-30 hours post-ICSI/insemination |
| Timing of Early Cleavage Stages (t2-t8) | 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) | Time from fertilization to the beginning of blastomere compaction. | Day 3-4 post-fertilization (up to ~96 hours) |
| Time of morula (tM) | Time from fertilization to the formation of a compact morula stage embryo. | Day 4 post-fertilization (up to 120 hours) |
| Time of cavitation (tSB) | 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) | 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 | Number of embryos reaching the blastocyst stage by Day 5 of development. | Day 5 post-fertilization |
| Total number of Day 6 blastocysts | Number of embryos reaching the blastocyst stage by Day 6 of development. | Day 5 post-fertilization |
| Total number of Day 7 blastocysts | Number of embryos reaching the blastocyst stage by Day 7 of development. | Day 5 post-fertilization |
| Total number of euploid embryos | 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 | Proportion of mature (MII) oocytes that develop into blastocysts. | From oocyte retrieval to blastocyst stage (up to Day 5-7) |
| Number of embryos cryopreserved | Total number of embryos suitable for vitrification following culture. | At end of embryo culture (Day 5-7) |
| Clinical pregnancy rate | Presence of one or more intrauterine gestational sacs confirmed by ultrasound. | At 5-7 weeks of gestation |
| Ongoing Pregnancy Rate | 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 | 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 | 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) |
| Dexeus Mujer Sant Cugat | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
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| Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus | Barcelona | 08037 | Spain |
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| Dexeus Mujer Tarragona | Tarragona | 43206 | Spain |
|
| 9563682 | 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. |
| 32416978 | 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. |
| 17640944 | 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. |
| 16873892 | 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. |
| 9604764 | 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. |
| 33118716 | 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. |
| 34154604 | 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. |
| 12909504 | 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. |
| 15388674 | 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. |