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| Name | Class |
|---|---|
| Centro de Estudios e Investigaciones en Biología y Medicina Reproductiva | UNKNOWN |
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It has been reported that the potential of In Vitro matured oocytes might be affected by the vitrification process. In fact, the freezing and thawing procedures routinely used in IVF laboratories, have not yet been adapted to oocytes coming from early antral follicles (normally used for In Vitro Maturation).
This study aims to compare 2 existing protocols for the Vitrification of In Vitro matured oocytes.
This is a single-center non-blinded observational study.
The proposed study will follow a sibling oocyte design in infertile patients. In Vitro Maturation will be performed by using the Capacitation-IVM (CAPA-IVM) methodology.
All cumulus-oocyte complexes (COC) recovered from the patient will be cultured in CAPA medium for 24 hours and then matured for 30 hours (IVM). A minimum of 10 metaphase II (MII) stage oocytes are expected from each CAPA-IVM procedure.
After CAPA-IVM culture, the mature oocytes (MII) will be randomly divided (50/50) into two groups to be subjected to the two vitrification protocols.
In a second step (next cycle), the oocytes from each group will be thawed and fertilized by Intracytoplasmic sperm injection (ICSI). The derived embryos will be cultured to the blastocyst stage (Day 5/6).
The transfer of a single embryo (the one with the best quality) will be carried out. The remaining embryos will be vitrified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation of Vitrification medium #1 | Hydroxypropyl cellulose (HPC), Ethylene glycol, Dimethyl sulfoxide (DMSO) y trehalose |
| |
| Formulation of Vitrification medium #2 | Human serum albumin (HSA), Ethylene glycol, Dimethyl sulfoxide (DMSO) & sucrose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oocyte Vitrification /Warming | Procedure | In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oocyte survival rate | The survival rate will be calculated by dividing the number of oocytes that survive freezing/thawing by the number of oocytes originally frozen. Survival rate will be evaluated per patient, per vitrification protocol. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oocyte maturation rate | The maturation rate will be calculated by dividing the number of oocytes that mature by the number of oocytes originally plated. | 6 months |
| Fertilization rate | The fertilization rate will be calculated by dividing the number of fertilized oocytes by the number of oocytes injected by ICSI. |
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Inclusion Criteria:
Either
In both cases, without significant uterine or ovarian anomalies
Exclusion Criteria:
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Infertile patients that are subjected to In Vitro maturation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergio Romero, PhD | Contact | +51-1-2230363 | sergioromero@cefra.com.pe |
| Name | Affiliation | Role |
|---|---|---|
| Sergio Romero, PhD | Research Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Fertilidad y Reproducción Asistida | Recruiting | Lima | 15036 | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35275746 | Background | Salama M, Ataman L, Taha T, Azmy O, Braham M, Douik F, Khrouf M, Rodrigues JK, Reis FM, Sanchez F, Romero S, Vega M, Woodruff TK. Building Oncofertility Core Competency in Developing Countries: Experience From Egypt, Tunisia, Brazil, Peru, and Panama. JCO Glob Oncol. 2020 Mar 2;6:360-368. doi: 10.1200/GO.22.00006. eCollection 2020. | |
| 35275733 |
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| 6 months |
| Cleavage rate | The cleavage rate will be calculated by dividing the number of cleaving embryos by the number of fertilized oocytes. | 6 months |
| Rate of Blastocyst formation | The rate of blastocyst formation will be calculated by dividing the number of blastocysts by the number of fertilized oocytes. | 6 months |
| Rate of Good quality blastocysts | The rate of good quality blastocysts will be calculated by dividing the number of good quality blastocysts by the number of fertilized oocytes. | 6 months |
| Clinical pregnancy rate | The clinical pregnancy rate will be calculated by dividing the number of patients with clinical pregnancy by the number of patients that underwent embryo transfer procedures. | 15 months |
| Live birth rate | The live birth rate will be calculated by dividing the number of patients with a live birth by the number of patients that underwent embryo transfer procedures. | 15 months |
| Erratum. JCO Glob Oncol. 2022 Mar;8:e2100412. doi: 10.1200/GO.21.00412. No abstract available. |
| 31902102 | Background | Vuong LN, Le AH, Ho VNA, Pham TD, Sanchez F, Romero S, De Vos M, Ho TM, Gilchrist RB, Smitz J. Live births after oocyte in vitro maturation with a prematuration step in women with polycystic ovary syndrome. J Assist Reprod Genet. 2020 Feb;37(2):347-357. doi: 10.1007/s10815-019-01677-6. Epub 2020 Jan 4. |
| 31399916 | Background | Sanchez F, Le AH, Ho VNA, Romero S, Van Ranst H, De Vos M, Gilchrist RB, Ho TM, Vuong LN, Smitz J. Biphasic in vitro maturation (CAPA-IVM) specifically improves the developmental capacity of oocytes from small antral follicles. J Assist Reprod Genet. 2019 Oct;36(10):2135-2144. doi: 10.1007/s10815-019-01551-5. Epub 2019 Aug 9. |
| 33132059 | Background | Braam SC, Ho VNA, Pham TD, Mol BW, van Wely M, Vuong LN. In-vitro maturation versus IVF: a cost-effectiveness analysis. Reprod Biomed Online. 2021 Jan;42(1):143-149. doi: 10.1016/j.rbmo.2020.09.022. Epub 2020 Sep 28. |
| 26754749 | Background | Coello A, Campos P, Remohi J, Meseguer M, Cobo A. A combination of hydroxypropyl cellulose and trehalose as supplementation for vitrification of human oocytes: a retrospective cohort study. J Assist Reprod Genet. 2016 Mar;33(3):413-421. doi: 10.1007/s10815-015-0633-9. Epub 2016 Jan 11. |
| 29869219 | Background | Cohen Y, St-Onge-St-Hilaire A, Tannus S, Younes G, Dahan MH, Buckett W, Son WY. Decreased pregnancy and live birth rates after vitrification of in vitro matured oocytes. J Assist Reprod Genet. 2018 Sep;35(9):1683-1689. doi: 10.1007/s10815-018-1216-3. Epub 2018 Jun 4. |