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Embryo Developmental Potential in a Novel 2-step IVM System

NCT04285892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-11-25

No results posted yet for this study

Summary

In vitro maturation is a valid option for PCO(S) patients in the daily ART clinic, however maturation and embryologic development are not yet matching the efficiency levels obtained by standard COS treatment. To further enhance embryo quality after IVM, it was hypothesized to keep the connection and communication between oocyte and cumulus cells intact for a prolonged pre-maturation culture before IVM was initiated. This has been investigated and established using a meiotic blocker C-type Natriuretic peptide (CNP).

The CNP peptide is present in high concentrations in the growing follicle, is produced by the mural granulosa cell compartment and binds to the Natriuretic peptide receptor 2 (NRP2) present in the cumulus cells. Binding of CNP on NRP2 leads to intracellular cGMP increase in cumulus cells, which travels through the transzonal projections to the oocyte. In the oocyte, cGMP will block the resumption of meiosis.

Using CNP as natural inhibitor of meiosis, a new medium was designed to allow oocyte and surrounding cumulus cells to communicate and hence gain in competence for an additional culture period: the pre-maturation phase or Capacitation phase (CAPA). This system was devel-oped in mouse, tested in human in UZ Brussel on research material (toelating federaal EC: CFE-FCE ADV\_073\_ZUBrussel, toelating lokaal EC: 2016/411 BUN 143201630723) and used in a clinical setting in Vietnam.

Conditions

  • In Vitro Maturation of Oocytes

Interventions

DEVICE

CAPA-IVM

CAPA medium keeps oocytes in meiotic arrest for 22-24 hours. IVM medium allows oocytes to resume meiosis. CAPA medium: 10% human serum albumin (HSA) + 10nM estradiol (E2) + 25nM CNP + 5ng/ml Insulin + 1mIU/ml follicle stimulating hormone (FSH) IVM medium: 10% HSA + 10nM E2 + 5ng/ml Insulin + 101mIU/ml FSH + 100ng/ml AREG CNP: peptide naturally occurring in follicles to maintain meiotic arrest, E2: estrogen, enhances effects of CNP, Insulin: basic growth factor used in cell cultures and component of commercially available LAG medium of the standard IVM system, AREG: downstream effector of the LHCG receptor which helps meiotic resumption. HSA, FSH and hCG are CE labeled. CAPA IVM medium is currently not yet available as CE marked commercially available medium and needs to be prepared in house.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Michel De Vos, MD, PhD · VUB- UZ Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2021-05-30
Completion
2023-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285892 on ClinicalTrials.gov