Vitrification of Oocytes Matured by CAPA-IVM

NCT06157619 | Unknown DMC

• 1 other identifier: SIDISI 23001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Preservation

Keywords

In Vitro maturation; Oocyte vitrification; Fertility preservation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Oocyte maturation rate

  6 months

• Fertilization rate

  6 months

• Cleavage rate

  6 months

• Rate of Blastocyst formation

  6 months

• Rate of Good quality blastocysts

  6 months

Study Arms (2)

Formulation of Vitrification medium #1

Hydroxypropyl cellulose (HPC), Ethylene glycol, Dimethyl sulfoxide (DMSO) y trehalose

Procedure: Oocyte Vitrification /Warming

Formulation of Vitrification medium #2

Human serum albumin (HSA), Ethylene glycol, Dimethyl sulfoxide (DMSO) \& sucrose

Procedure: Oocyte Vitrification /Warming

Interventions

Oocyte Vitrification /Warming PROCEDURE

In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols

Formulation of Vitrification medium #1; Formulation of Vitrification medium #2

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile patients that are subjected to In Vitro maturation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Fertilidad y Reproducción Asistida, Peru: lead
• Centro de Estudios e Investigaciones en Biología y Medicina Reproductiva: collaborator

Study Sites (1)

Centro de Fertilidad y Reproducción Asistida

Lima, 15036, Peru

RECRUITING

Related Publications (7)

• 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.

  PMID: 35275746 BACKGROUND

• Erratum. JCO Glob Oncol. 2022 Mar;8:e2100412. doi: 10.1200/GO.21.00412. No abstract available.

  PMID: 35275733 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.

  PMID: 31902102 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.

  PMID: 31399916 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.

  PMID: 33132059 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.

  PMID: 26754749 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.

  PMID: 29869219 BACKGROUND

Study Officials

• Sergio Romero, PhD

  Research Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Romero, PhD

CONTACT

+51-1-2230363; sergioromero@cefra.com.pe

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 17 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)