In Vitro Maturation of Oocytes Clinical Trial
— CAPA-IVM-SibOfficial title:
Trial Investigating the Developmental Potential of Embryos Obtained After Biphasic in Vitro Oocyte Maturation (IVM) of Oocytes Including a Pre Maturation Culture Step ('Capacitation Step') Compared With Standard IVM.
Verified date | January 2023 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 23 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | Inclusion Criteria: - PCO(S) patients - Anti-Mullerian Hormone = 3.6 ng/mL - Basal Antral Follicle Count = 20 - All ranks of trial Exclusion Criteria: - Surgically obtained semen sample - Grade 3 or 4 endometriosis, minor or major uterine abnormalities - Preimplantation Genetic Testing - Priming with Letrozole |
Country | Name | City | State |
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Belgium | UZ Brussel | Brussels |
Lead Sponsor | Collaborator |
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Universitair Ziekenhuis Brussel |
Belgium,
Romero S, Sanchez F, Lolicato F, Van Ranst H, Smitz J. Immature Oocytes from Unprimed Juvenile Mice Become a Valuable Source for Embryo Production When Using C-Type Natriuretic Peptide as Essential Component of Culture Medium. Biol Reprod. 2016 Sep;95(3):64. doi: 10.1095/biolreprod.116.139808. Epub 2016 Aug 3. — View Citation
Saenz-de-Juano MD, Ivanova E, Romero S, Lolicato F, Sanchez F, Van Ranst H, Krueger F, Segonds-Pichon A, De Vos M, Andrews S, Smitz J, Kelsey G, Anckaert E. DNA methylation and mRNA expression of imprinted genes in blastocysts derived from an improved in vitro maturation method for oocytes from small antral follicles in polycystic ovary syndrome patients. Hum Reprod. 2019 Sep 29;34(9):1640-1649. doi: 10.1093/humrep/dez121. — 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
Sanchez F, Lolicato F, Romero S, De Vos M, Van Ranst H, Verheyen G, Anckaert E, Smitz JEJ. An improved IVM method for cumulus-oocyte complexes from small follicles in polycystic ovary syndrome patients enhances oocyte competence and embryo yield. Hum Reprod. 2017 Oct 1;32(10):2056-2068. doi: 10.1093/humrep/dex262. — 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
Type | Measure | Description | Time frame | Safety issue |
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Primary | oocyte maturation | the ability of the oocyte to extrude the first polar body | oocyte maturation is assessed after 30 hours in the standard IVM protocol and after 54 hours after CAPA IVM | |
Secondary | Fertilization rate | the ability of the oocyte to be activated and form pronuclei | The presence of 2 pronuclei is assessed between 18-20 hours after ICSI | |
Secondary | morphologic parameters describing embryo quality per fertilized oocyte | embryo developmental potential as estimated by morphological characteristics: embryos with 6 cells or more, less than 20% fragmentation, cell size according to the division pattern and the absence of multinucleated blastomeres are considered as good quality embryos. As secondary parameters, the presence of vacuoles or granulation in the majority of blastomeres will exclude the embryo from the 'good quality' group regardless of the earlier mentioned parameters. | embryo developmental assessment is performed 3 days after ICSI | |
Secondary | utilization rate | the embryos of sufficient quality to be vitrified for a deferred embryo transfer | utilization rate will be established 3 days after ICSI | |
Secondary | embryo cryotolerance | the damage brought by the vitrification and warming process on cell survival within the embryo and the capacity of the vitrified/warmed embryo to resume cleavage divisions | First warming is done within one month after OPU in a new HRT cycle and repeated untill pregnancy up to 1 year after egg retrieval. |
Status | Clinical Trial | Phase | |
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Recruiting |
NCT05370794 -
Is in Vitro Maturation of Oocytes Influenced by the Origin of Gonadotropins Used in Maturation Medium: is There a Difference in Efficiency When Using Urinary Versus Recombinant Produced Follicle Stimulating Hormone and Human Chorionic Gonadotropin
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