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Single vs. Group CAPA-IVM Culture of Cumulus-oocyte Complexes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562883
Recruitment Status : Completed
First Posted : September 24, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Mỹ Đức Hospital

Study Description
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Brief Summary:
Oocyte in vitro maturation (IVM) is a minimal-stimulation ART with reduced hormone-related side effects and risks for the patients. However, the approach is not widely used because of an efficiency gap compared to conventional ART. In order to further optimize and adapt the CAPA-IVM system in the IVM clinic, this pilot study aims to check the feasibility of applying a single COC CAPA-IVM strategy versus the group COC culture CAPA-IVM

Condition or disease Intervention/treatment Phase
IVF PCOS IVM Other: The way of Cumulus-oocyte complexes (COC) culture Not Applicable

Detailed Description:

Oocyte in vitro maturation (IVM) is a minimal-stimulation ART with reduced hormone-related side effects and risks for the patients. However, the approach is not widely used because of an efficiency gap compared to conventional ART.

Oocytes retrieved for IVM procedures derive from a heterogeneous pool with variable cellular and molecular characteristics that indicate its immature status. Thus, in vitro systems that permit and enhance acquisition and synchronization of meiotic competence (ability to resume meiosis in response to an ovulatory stimulus) and developmental competence (ability to be fertilized and support early embryo development) before the meiotic trigger are crucial for the optimization of human IVM systems.

A novel two-step IVM culture system (named CAPA-IVM) involving a pre-maturation culture with C-type natriuretic peptide (CNP) and a maturation step in presence of Amphiregulin (AREG), both more physiological compounds improving oocyte competence, have been introduced in previous clinical studies. So far these pilot studies proved to increase the rates of oocyte maturation, good quality embryos on day 3, good quality blastocyst, and as a result a higher embryo yield. CAPA-IVM blastocysts have shown similar rates of methylation and gene expression at gDMRs compared to COS embryos; and the expression of ma-jor epigenetic regulators was similar between both groups. Furthermore, an improvement in pregnancy rates strengthens the clinical relevance of the use of CAPA-IVM strategy.

In order to further optimize and adapt the CAPA-IVM system in the IVM clinic, this pilot study aims to check the feasibility of applying a single COC CAPA-IVM strategy versus the group COC culture CAPA-IVM. A single COC culture would permit to perform a non-invasive molecular analysis per matured oocyte, in order to identify quality genes ex-pressed in cumulus cells post-IVM (cumulus biomarkers), which could be subsequently used to identify the embryo(s) with highest potential of implantation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Single vs. Group CAPA-IVM Culture of Human Cumulus-oocyte Complexes From Small Antral Follicles in a SIBLING Oocyte Study Design
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : December 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Culture
Transfer the COCs cultured individually in Capacitation medium to the individual washing droplets from the "washing dish" containing "Maturation Medium" and wash them thoroughly. Then transfer COCs one by one to the "Culture dish" with "Maturation Medium".
 Other: The way of Cumulus-oocyte complexes (COC) culture
Cumulus-oocyte complexes (COC) will be cultured in CAPA-IVM standard conditions: 24 hrs capacitation followed by 30h maturation. The first group will be culture in pools (group culture). The second group will be culture individually in 20µl droplets.
Experimental: Group Culture
Transfer half of the COCs (5-10 at a time) from the Capacitation culture dish to the "washing dish" containing "Maturation Medium (Group Culture)" by using an Eppendorf micropipette and wash them thoroughly (load pipette tips with 5µl, max. 10µl). Then transfer COCs to the "IVM dish" with "Maturation Medium (Group Culture)".
 Other: The way of Cumulus-oocyte complexes (COC) culture
Cumulus-oocyte complexes (COC) will be cultured in CAPA-IVM standard conditions: 24 hrs capacitation followed by 30h maturation. The first group will be culture in pools (group culture). The second group will be culture individually in 20µl droplets.


Outcome Measures
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Primary Outcome Measures :
  1. Number of good quality embryos [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]
    Number of good quality Day 3 embryos obtained


Secondary Outcome Measures :
  1. Maturation rate [ Time Frame: Two days after oocytes pick-up ]
    Percentage of mature oocytes by 2 types of COC culture

  2. Fertilization rate [ Time Frame: 16-18 hours after intra-cytoplasmic sperm injection ]
    Percentage of fertilized oocytes by 2 types of COC culture

  3. Cleavage rate [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]
    Percentage of day-3 embryos over fertilized oocytes by 2 types of COC culture

  4. Expansion rate [ Time Frame: After at least 30 hours of maturation culture ]
    Percentage of cumulus-oocyte complexes expanded after culture by 2 types of COC culture

  5. The relative expression ratio ( R ) of human cumulus cell genes [ Time Frame: cumulus cells will be collected after at least 30 hours of maturation culture, storaged at -80oC until RNA purification ]
    Cumulus cells will be collected, cDNA synthesis after mRNA purification, relative quantification PCR for detecting gene expression


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having polycystic ovarian morphology: at least 25 follicles (2-9 mm) throughout the whole ovary and/or increased ovarian volume (>10ml) (it is sufficient that 1 ovary fits these criteria)
  • No major uterine or ovarian abnormalities
  • Having at least 15 follicles on the OPU day
  • Patients consent to participate in the study

Exclusion Criteria:

  • High (>grade 2) grade endometriosis
  • Cases with extremely poor sperm (serve OAT: density <1 million, mobility <10% and sperm from testicular surgery)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562883


Locations
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Vietnam
My Duc Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Mỹ Đức Hospital
Investigators
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Principal Investigator: Tuong M Ho, MD, MCE Hope Research Center
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Mỹ Đức Hospital
ClinicalTrials.gov Identifier: NCT04562883    
Other Study ID Numbers: 13/20/DD-BVMD
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mỹ Đức Hospital:
CAPA-IVM
Single culture
Group culture