Vitrification of Oocytes Matured by CAPA-IVM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fertility Preservation

Intervention / Treatment
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* Procedure: Oocyte Vitrification /Warming


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Formulation of Vitrification medium #1<br>Hydroxypropyl cellulose (HPC), Ethylene glycol, Dimethyl sulfoxide (DMSO) y trehalose | Procedure: Oocyte Vitrification /Warming<br>* In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols<br>|
| Formulation of Vitrification medium #2<br>Human serum albumin (HSA), Ethylene glycol, Dimethyl sulfoxide (DMSO) & sucrose | Procedure: Oocyte Vitrification /Warming<br>* In Vitro matured oocytes will be randomly assigned to any of the two Vitrification protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In Vitro maturation, Oocyte vitrification, Fertility preservation