Clinical trial NCT06157619: Vitrification of Oocytes Matured by CAPA-IVM
Official title: Vitrification of In Vitro Matured Oocytes Following the CAPA-IVM Methodology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility Preservation
Keywords: In Vitro maturation
Oocyte vitrification
Fertility preservation
Lead sponsor: Centro de Fertilidad y Reproducción Asistida, Peru
Sponsor class: OTHER
Collaborators: name: Centro de Estudios e Investigaciones en Biología y Medicina Reproductiva
First posted: 2023-12-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile patients that are subjected to In Vitro maturation

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Either

* Patients with Polycystic ovary morphology: At least 25 follicles (2-9 mm) throughout the ovary and/or increased ovarian volume (\>10ml) (it is enough for 1 ovary to meet these criteria)
* Patients with good ovarian reserve: High antral follicle count (AFC): ≥ 20 antral follicles in both ovaries or Anti-müllerian hormone (AMH) value ≥3.5 ng/ml

In both cases, without significant uterine or ovarian anomalies

Exclusion Criteria:

* There are contraindications for the administration of gonadotropins, oral contraceptives and/or other drugs used in the framework of the present study.
* Preimplantation Genetic Testing (PGT) Cycles
* Oocyte donation cycles
* Medical contraindication for pregnancy.
* High grade endometriosis (\> grade 2)
* Cases with extremely poor sperm

Primary outcomes:
measure: Oocyte survival rate
timeFrame: 6 months
Secondary outcomes:
measure: Oocyte maturation rate
timeFrame: 6 months
measure: Fertilization rate
timeFrame: 6 months
measure: Cleavage rate
timeFrame: 6 months
measure: Rate of Blastocyst formation
timeFrame: 6 months
measure: Rate of Good quality blastocysts
timeFrame: 6 months
measure: Clinical pregnancy rate
timeFrame: 15 months
measure: Live birth rate
timeFrame: 15 months
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Centro de Fertilidad y Reproducción Asistida
Study officials:
affiliation: Research Director
name: Sergio Romero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Erratum. JCO Glob Oncol. 2022 Mar;8:e2100412. doi: 10.1200/GO.21.00412. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.