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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507028-22 | EudraCT Number |
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This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follitropin-delta 20 mcg/day from D1 | Experimental |
| |
| Follitropin-delta 15 mcg/day from D1 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin-delta (Rekovelle) 20 mcg/day from D1 | Drug | On day 2 or 3 of the menstrual cycle, daily injections of 20 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of euploid embryos | Number of euploid embryos | Trough study completion, an average of 20-30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Gonadotropin dose | Total gonadotropin dose used | Up to oocyte pickup, an average of 10-20 days |
| Length of stimulation | Days of stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaos P Polyzos, MD, PhD | Contact | 0034932274700 | nikpol@dexeus.com | |
| Ignacio RodrÃguez, MSc | Contact | 0034932274700 | 22029 | nacrod@dexeus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Quiron Dexeus | Recruiting | Barcelona | 08028 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28169189 | Background | Alper MM, Fauser BC. Ovarian stimulation protocols for IVF: is more better than less? Reprod Biomed Online. 2017 Apr;34(4):345-353. doi: 10.1016/j.rbmo.2017.01.010. Epub 2017 Jan 24. | |
| 32819842 | Background | Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| C000620228 | follitropin delta |
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| Follitropin-delta (Rekovelle) 15 mcg/day from D1 | Drug | On day 2 or 3 of the menstrual cycle, daily injections of 15 mcg of Rekovelle (Stimulation Day 1) will be administered. Scan controls and blood exams are performed on stimulation days 6, 8, 10 and, according to clinical needs, until trigger day. The dose will be the same during the whole course of stimulation and no dose adjustments will be performed. |
|
| Up to oocyte pickup, an average of 10-20 days |
| Estradiol | Estradiol level | Up to oocyte pickup, an average of 10-20 days |
| Progesterone | Progesterone level | Up to oocyte pickup, an average of 10-20 days |
| LH | LH level | Up to oocyte pickup, an average of 10-20 days |
| Follicular Output RaTe (FORT) | ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation | Day one of stimulation. 1 Day |
| Cycle cancelation rate | Cycle cancelation rate | Up to oocyte pickup, an average of 10-20 days |
| Fertilization rate | Fertilization rate | Up to one day after oocyte pickup, an average of 10-20 days |
| Time of appearance of the 2nd polar body (tPB2) | Time of appearance of the 2nd polar body (tPB2) | Up to one day after oocyte pickup, an average of 10-20 days |
| Time of pronuclei disappearance (tPNf) | Up to one day after oocyte pickup, an average of 10-20 days |
| Time of division from 2 to 8 cells | Until 1, or 4 days after insemination |
| Time of compactation (tSC) | Until 3, or 4 days after insemination |
| Time of morula (tM) | Until 4 or 7 days after insemination |
| Time of cavitation (tSB) | Until 4 or 7 days after insemination |
| Time of full blastulation (tB) | Until 4 or 7 days after insemination |
| Total number of day 5 blastocysts | Until 5, 6 or 7 days after insemination |
| Total number of good quality blastocysts | Until 5, 6 or 7 days after insemination |
| Total number of embryos | Until 5, 6 or 7 days after insemination |
| Blastocyst formation rate | proportion of 2PN zygotes that reach the blastocyst stage | Until 5, 6 or 7 days after insemination |
| Number of embryos cryopreserved | Until 5, 6 or 7 days after insemination |
| Embryo stage | Until 5, 6 or 7 days after insemination |
| Clinical pregnancy rate | defined as the visualization of one or more gestational sacs | 5-6 weeks after transfer |
| Ongoing pregnancy rate | defined as a viable intrauterine pregnancy | 8-10 weeks after transfer |
| 17204525 | Background | Baart EB, Martini E, Eijkemans MJ, Van Opstal D, Beckers NG, Verhoeff A, Macklon NS, Fauser BC. Milder ovarian stimulation for in-vitro fertilization reduces aneuploidy in the human preimplantation embryo: a randomized controlled trial. Hum Reprod. 2007 Apr;22(4):980-8. doi: 10.1093/humrep/del484. Epub 2007 Jan 4. |
| 25362088 | Background | Briggs R, Kovacs G, MacLachlan V, Motteram C, Baker HW. Can you ever collect too many oocytes? Hum Reprod. 2015 Jan;30(1):81-7. doi: 10.1093/humrep/deu272. Epub 2014 Oct 31. |
| 30272168 | Background | Devesa M, Tur R, Rodriguez I, Coroleu B, Martinez F, Polyzos NP. Cumulative live birth rates and number of oocytes retrieved in women of advanced age. A single centre analysis including 4500 women >/=38 years old. Hum Reprod. 2018 Nov 1;33(11):2010-2017. doi: 10.1093/humrep/dey295. |
| 24355045 | Background | Franasiak JM, Forman EJ, Hong KH, Werner MD, Upham KM, Treff NR, Scott RT Jr. The nature of aneuploidy with increasing age of the female partner: a review of 15,169 consecutive trophectoderm biopsies evaluated with comprehensive chromosomal screening. Fertil Steril. 2014 Mar;101(3):656-663.e1. doi: 10.1016/j.fertnstert.2013.11.004. Epub 2013 Dec 17. |
| 32348476 | Background | Irani M, Canon C, Robles A, Maddy B, Gunnala V, Qin X, Zhang C, Xu K, Rosenwaks Z. No effect of ovarian stimulation and oocyte yield on euploidy and live birth rates: an analysis of 12 298 trophectoderm biopsies. Hum Reprod. 2020 May 1;35(5):1082-1089. doi: 10.1093/humrep/deaa028. |
| 16580375 | Background | Kok JD, Looman CW, Weima SM, te Velde ER. A high number of oocytes obtained after ovarian hyperstimulation for in vitro fertilization or intracytoplasmic sperm injection is not associated with decreased pregnancy outcome. Fertil Steril. 2006 Apr;85(4):918-24. doi: 10.1016/j.fertnstert.2005.09.035. |
| 28987789 | Background | La Marca A, Minasi MG, Sighinolfi G, Greco P, Argento C, Grisendi V, Fiorentino F, Greco E. Female age, serum antimullerian hormone level, and number of oocytes affect the rate and number of euploid blastocysts in in vitro fertilization/intracytoplasmic sperm injection cycles. Fertil Steril. 2017 Nov;108(5):777-783.e2. doi: 10.1016/j.fertnstert.2017.08.029. Epub 2017 Oct 4. |
| 36707342 | Background | Neves AR, Montoya-Botero P, Sachs-Guedj N, Polyzos NP. Association between the number of oocytes and cumulative live birth rate: A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Mar;87:102307. doi: 10.1016/j.bpobgyn.2022.102307. Epub 2022 Dec 27. |
| 30196963 | Background | Polyzos NP, Drakopoulos P, Parra J, Pellicer A, Santos-Ribeiro S, Tournaye H, Bosch E, Garcia-Velasco J. Cumulative live birth rates according to the number of oocytes retrieved after the first ovarian stimulation for in vitro fertilization/intracytoplasmic sperm injection: a multicenter multinational analysis including approximately 15,000 women. Fertil Steril. 2018 Sep;110(4):661-670.e1. doi: 10.1016/j.fertnstert.2018.04.039. |
| 30842755 | Background | Ubaldi FM, Cimadomo D, Vaiarelli A, Fabozzi G, Venturella R, Maggiulli R, Mazzilli R, Ferrero S, Palagiano A, Rienzi L. Advanced Maternal Age in IVF: Still a Challenge? The Present and the Future of Its Treatment. Front Endocrinol (Lausanne). 2019 Feb 20;10:94. doi: 10.3389/fendo.2019.00094. eCollection 2019. |
| 30476100 | Background | Venetis CA, Tilia L, Panlilio E, Kan A. Is more better? A higher oocyte yield is independently associated with more day-3 euploid embryos after ICSI. Hum Reprod. 2019 Jan 1;34(1):79-83. doi: 10.1093/humrep/dey342. |
| 30137360 | Background | Wu Q, Li H, Zhu Y, Jiang W, Lu J, Wei D, Yan J, Chen ZJ. Dosage of exogenous gonadotropins is not associated with blastocyst aneuploidy or live-birth rates in PGS cycles in Chinese women. Hum Reprod. 2018 Oct 1;33(10):1875-1882. doi: 10.1093/humrep/dey270. |