Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2023-12-31
2025-03-31
Brief Summary
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This study aims to compare 2 existing protocols for the Vitrification of In Vitro matured oocytes.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Formulation of Vitrification medium #1
Hydroxypropyl cellulose (HPC), Ethylene glycol, Dimethyl sulfoxide (DMSO) y trehalose
Oocyte Vitrification /Warming
In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols
Formulation of Vitrification medium #2
Human serum albumin (HSA), Ethylene glycol, Dimethyl sulfoxide (DMSO) \& sucrose
Oocyte Vitrification /Warming
In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols
Interventions
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Oocyte Vitrification /Warming
In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols
Eligibility Criteria
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Inclusion Criteria
* 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
* Preimplantation Genetic Testing (PGT) Cycles
* Oocyte donation cycles
* Medical contraindication for pregnancy.
* High grade endometriosis (\> grade 2)
* Cases with extremely poor sperm
20 Years
37 Years
FEMALE
Yes
Sponsors
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Centro de Estudios e Investigaciones en Biología y Medicina Reproductiva
UNKNOWN
Centro de Fertilidad y Reproducción Asistida, Peru
OTHER
Responsible Party
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Sergio Romero
Research Director
Principal Investigators
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Sergio Romero, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Director
Locations
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Centro de Fertilidad y Reproducción Asistida
Lima, , Peru
Countries
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Central Contacts
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Facility Contacts
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Ygor Pérez, M.D. MSc
Role: primary
References
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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.
Erratum. JCO Glob Oncol. 2022 Mar;8:e2100412. doi: 10.1200/GO.21.00412. No abstract available.
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.
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.
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.
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.
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.
Other Identifiers
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SIDISI 23001
Identifier Type: -
Identifier Source: org_study_id