AzTrials
AzTrials

IVFNCT04562883

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

A study testing The way of Cumulus-oocyte complexes (COC) culture in people with IVF and PCOS, run by Mỹ Đức Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 37 years, women onlyHealthy volunteers can take part
Conditions the study is for
IVF, PCOS, IVM
What is being tested?
The way of Cumulus-oocyte complexes (COC) culture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteVietnam
Study dates
1 Oct 2020to 24 Oct 2021
Phase
Interventional
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 18 to 37 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • High (>grade 2) grade endometriosis
  • Cases with extremely poor sperm (serve OAT: density <1 million, mobility <10% and sperm from testicular surgery)

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • My Duc Hospital

    Ho Chi Minh City

Other trials in Vietnam

About this study

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

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

Read the 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.

Conditions
IVF, PCOS, IVM
Being tested
The way of Cumulus-oocyte complexes (COC) culture
Keywords
CAPA-IVM, Single culture, Group culture

What participants receive

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

  • The way of Cumulus-oocyte complexes (COC) cultureOther

    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.

Study groups in NCT04562883
Study groupRoleWhat they receive
Single CultureExperimentalTransfer 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".
Receives: Other: The way of Cumulus-oocyte complexes (COC) culture
Group CultureExperimentalTransfer 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)".
Receives: Other: The way of Cumulus-oocyte complexes (COC) culture

What is being measured

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

  1. Number of good quality embryos

    Number of good quality Day 3 embryos obtained

    Measured: At least 3 days after intra-cytoplasmic sperm injection

Secondary outcomes (13)

  1. Maturation rate

    Percentage of mature oocytes by 2 types of COC culture

    Measured: Two days after oocytes pick-up

  2. Fertilization rate

    Percentage of fertilized oocytes by 2 types of COC culture

    Measured: 16-18 hours after intra-cytoplasmic sperm injection

  3. Cleavage rate

    Percentage of day-3 embryos over fertilized oocytes by 2 types of COC culture

    Measured: At least 3 days after intra-cytoplasmic sperm injection

  4. Expansion rate

    Percentage of cumulus-oocyte complexes expanded after culture by 2 types of COC culture

    Measured: After at least 30 hours of maturation culture

  5. The relative expression ratio ( R ) of human cumulus cell genes

    Cumulus cells will be collected, cDNA synthesis after mRNA purification, relative quantification PCR for detecting gene expression

    Measured: cumulus cells will be collected after at least 30 hours of maturation culture, storaged at -80oC until RNA purification

  6. Positive pregnancy test

    Serum human chorionic gonadotropin level greater than 25 mIU/mL

    Measured: at 2 weeks after the embryo placement after the completion of the first transfer

  7. Clinical pregnancy

    at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity

    Measured: 5 weeks after embryo placement after the completion of the first transfer

  8. Ongoing pregnancy

    Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer

    Measured: At 12 weeks' gestation

  9. Implantation rate

    as the number of gestational sacs per number of embryos transferred

    Measured: 3 weeks after embryo transferred after the completion of the first transfer

  10. Multiple pregnancy

    Defined as presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation)

    Measured: 5 weeks after embryo placement after the completion of the first transfer

  11. Multiple delivery

    Birth of more than one baby beyond 24 weeks

    Measured: At 24 weeks' gestation

  12. Miscarriage

    pregnancy loss at < 24 weeks

    Measured: at 24 weeks of gestation after the completion of the first transfer

  13. Live birth

    defined as at least one newborn after 24 weeks of gestation and exhibiting any sign of life; twins were counted as a single birth

    Measured: At 24 weeks of gestation

Timeline

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

  1. First posted24 Sep 2020
  2. Study start1 Oct 2020
  3. Primary completion30 Nov 2020
  4. Study completion24 Oct 2021

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04562883
Sponsor's protocol ID
13/20/DD-BVMD
Status last verified
Jul 2023
First submitted
5 Sep 2020
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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, Romero S, De Vos M, Verheyen G, Smitz J. Human cumulus-enclosed germinal vesicle oocytes from early antral follicles reveal heterogeneous cellular and molecular features associated with in vitro maturation capacity. Hum Reprod. 2015 Jun;30(6):1396-409. doi: 10.1093/humrep/dev083. Epub 2015 Apr 22.

    PubMed 25904637

  • Saenz-de-Juano MD, Ivanova E, Billooye K, Herta AC, Smitz J, Kelsey G, Anckaert E. Genome-wide assessment of DNA methylation in mouse oocytes reveals effects associated with in vitro growth, superovulation, and sexual maturity. Clin Epigenetics. 2019 Dec 19;11(1):197. doi: 10.1186/s13148-019-0794-y.

    PubMed 31856890

  • 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.

    PubMed 28938744

Questions about this trial

What is this clinical trial studying?

A study testing The way of Cumulus-oocyte complexes (COC) culture in people with IVF and PCOS, run by Mỹ Đức Hospital at 1 site in Vietnam.

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 2 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: finished, as of the sponsor's last update on 25 Jul 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 Vietnam. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of good quality embryos (time frame: At least 3 days after intra-cytoplasmic sperm injection). 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 NCT04562883, which also lists 5 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 25 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in