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

NCT04562883 | Completed

• 1 other identifier: 13/20/DD-BVMD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

IVF; PCOS; IVM

Keywords

CAPA-IVM; Single culture; Group culture

Outcome Measures

Primary Outcomes (1)

• Number of good quality embryos

  Number of good quality Day 3 embryos obtained

  At least 3 days after intra-cytoplasmic sperm injection

Secondary Outcomes (13)

• Maturation rate

  Two days after oocytes pick-up

• Fertilization rate

  16-18 hours after intra-cytoplasmic sperm injection

• Cleavage rate

  At least 3 days after intra-cytoplasmic sperm injection

• Expansion rate

  After at least 30 hours of maturation culture

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

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

Study Arms (2)

Single Culture

EXPERIMENTAL

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

Group Culture

EXPERIMENTAL

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

Interventions

The way of Cumulus-oocyte complexes (COC) culture OTHER

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.

Group Culture; Single Culture

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (5)

• 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.

  PMID: 31399916 BACKGROUND

• 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.

  PMID: 31902102 BACKGROUND

• 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.

  PMID: 25904637 BACKGROUND

• 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.

  PMID: 31856890 BACKGROUND

• 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.

  PMID: 28938744 RESULT

MeSH Terms

Interventions

Culture Techniques

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• Tuong M Ho, MD, MCE

  Hope Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: October 24, 2021
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)