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AzTrials

Fertility PreservationNCT06157619

Vitrification of Oocytes Matured by CAPA-IVM

An observational study of Fertility Preservation, run by Centro de Fertilidad y Reproducción Asistida, Peru at 1 site in Peru.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 20 to 37 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fertility Preservation
What is being tested?
Oocyte Vitrification /Warming
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 sitePeru
Study dates
Dec 2023to Mar 2025
How long will I take part?
17 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 37 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Infertile patients that are subjected to In Vitro maturation

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sergio Romero, PhD contact

+51-1-2230363

sergioromero@cefra.com.pe

Peru1 site, 1 recruiting

  • Centro de Fertilidad y Reproducción Asistida

    Lima, 15036

    Ygor Pérez, M.D. MSc

    Francisco Escudero, M.D., MSc

    Recruiting

Other trials in Peru

About this study

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

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.

Read the 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.

Being tested
Oocyte Vitrification /Warming
Keywords
In Vitro maturation, Oocyte vitrification, Fertility preservation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oocyte Vitrification /WarmingProcedure or surgery

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

Study groups in NCT06157619
Study groupRoleWhat they receive
Formulation of Vitrification medium #1Hydroxypropyl cellulose (HPC), Ethylene glycol, Dimethyl sulfoxide (DMSO) y trehalose
Receives: Procedure: Oocyte Vitrification /Warming
Formulation of Vitrification medium #2Human serum albumin (HSA), Ethylene glycol, Dimethyl sulfoxide (DMSO) \& sucrose
Receives: Procedure: Oocyte Vitrification /Warming

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (7)

  1. Oocyte maturation rate

    The maturation rate will be calculated by dividing the number of oocytes that mature by the number of oocytes originally plated.

    Measured: 6 months

  2. Fertilization rate

    The fertilization rate will be calculated by dividing the number of fertilized oocytes by the number of oocytes injected by ICSI.

    Measured: 6 months

  3. Cleavage rate

    The cleavage rate will be calculated by dividing the number of cleaving embryos by the number of fertilized oocytes.

    Measured: 6 months

  4. Rate of Blastocyst formation

    The rate of blastocyst formation will be calculated by dividing the number of blastocysts by the number of fertilized oocytes.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. 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.

    Measured: 15 months

  7. 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.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
Target duration
17 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06157619
Sponsor's protocol ID
SIDISI 23001
Status last verified
Dec 2023
First submitted
27 Nov 2023
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35275746

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

    PubMed 35275733

  • 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.

    PubMed 31902102

  • 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.

    PubMed 31399916

  • 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.

    PubMed 33132059

  • 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.

    PubMed 26754749

  • 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.

    PubMed 29869219

Questions about this trial

What is this clinical trial studying?

An observational study of Fertility Preservation, run by Centro de Fertilidad y Reproducción Asistida, Peru at 1 site in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sergio Romero, PhD (+51-1-2230363, sergioromero@cefra.com.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oocyte survival rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06157619, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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