Vitrification of Oocytes Matured by CAPA-IVM

Fertility Preservation Clinical Trial

Official title:

Vitrification of In Vitro Matured Oocytes Following the CAPA-IVM Methodology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157619
• Other study ID #: SIDISI 23001
• Status: Recruiting
• Start date: December 2023
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: Centro de Fertilidad y Reproducción Asistida, Peru
• Contact: Sergio Romero, PhD
• Phone: +51-1-2230363
• Email: sergioromero[@]cefra.com.pe
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Preservation

Intervention

Procedure:
• Oocyte Vitrification /Warming
In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols

Locations

Country	Name	City	State
Peru	Centro de Fertilidad y Reproducción Asistida	Lima

Sponsors (2)

Lead Sponsor	Collaborator
Centro de Fertilidad y Reproducción Asistida, Peru	Centro de Estudios e Investigaciones en Biología y Medicina Reproductiva

Country where clinical trial is conducted

Peru, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

Erratum. JCO Glob Oncol. 2022 Mar;8:e2100412. doi: 10.1200/GO.21.00412. No abstract available. — View 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 Nov;6:360-368. doi: 10.1200/GO.22.00006. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Fertilization rate	The fertilization rate will be calculated by dividing the number of fertilized oocytes by the number of oocytes injected by ICSI.	6 months
Secondary	Cleavage rate	The cleavage rate will be calculated by dividing the number of cleaving embryos by the number of fertilized oocytes.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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