Low vs. Air Oxygen Concentration CAPA-IVM Culture of Cumulus-oocyte Complexes

NCT06087354 | Completed

• 1 other identifier: 11/23/DD-BVMD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

IVM with a pre-maturation step, known as capacitation IVM (CAPA-IVM), has demonstrated enhanced maturation of human oocytes in vitro and successful live births. However, CAPA-IVM has shown lower rates of embryo formation when compared to conventional in vitro fertilization/ intra cytoplasmic sperm injection (IVF/ICSI) cycles. To optimize the CAPA-IVM culture system, this pilot study aims to evaluate the impact of low oxygen versus air oxygen concentrations on embryological outcomes in PCOS patients.

Conditions

IVM; PCOS (Polycystic Ovary Syndrome)

Keywords

Low oxygen; CAPA-IVM; Cumulus-oocyte complexes

Outcome Measures

Primary Outcomes (1)

• Number of blastocyst

  Number of blastocyst obtained

  At least 5 days after intra-cytoplasmic sperm injection

Secondary Outcomes (12)

• Number of matured oocytes

  Two days after oocytes pick-up

• Number of normal fertilized oocytes

  16-18 hours after intra-cytoplasmic sperm injection

• Number of day-3 embryos

  At least 3 days after intra-cytoplasmic sperm injection

• Number of good-quality day-3 embryos

  At least 3 days after intra-cytoplasmic sperm injection

• Number of good-quality blastocyst

  At least 5 days after intra-cytoplasmic sperm injection

Study Arms (2)

Low Oxygen Concentration CAPA-IVM culture

EXPERIMENTAL

Half of COCs were cultured in the CAPA step and IVM step in a low oxygen concentration (5%) and 6% carbon dioxide at 37 degree

Other: The way of Cumulus-oocyte complexes (COC) CAPA-IVM culture condition

Air Oxygen Concentration CAPA-IVM culture

EXPERIMENTAL

Half of COCs were cultured in the CAPA step and IVM step in a air oxygen concentration (20%) and 6% carbon dioxide at 37 degree

Other: The way of Cumulus-oocyte complexes (COC) CAPA-IVM culture condition

Interventions

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

Cumulus-oocyte complexes (COC) will be cultured in CAPA-IVM 24 hrs capacitation followed by 30h maturation. The first group will be cultured in low oxygen concentration (5%Oxygen), 6% carbon dioxide at 37 degree. The second group will be cultured in air oxygen concentration (20%Oxygen), 6% carbon dioxide at 37 degree.

Air Oxygen Concentration CAPA-IVM culture; Low Oxygen Concentration CAPA-IVM culture

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≤38 years
• Having polycystic ovarian morphology: at least 25 follicles (2-9 mm) throughout the whole ovary and/or increased ovarian volume (\>10ml)
• Having at least 20 follicles on the Oocyte Pick-up day
• Patients consent to culture embryos to the blastocyst

You may not qualify if:

• Cases with severe male factor (concentration \<5 million/ml, cryptozoospermia, azoospermia)
• Oocyte donation
• Pre-implantation genetic testing

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, 70000, 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, Ho VNA, Ho TM, Dang VQ, Phung TH, Giang NH, Le AH, Pham TD, Wang R, Smitz J, Gilchrist RB, Norman RJ, Mol BW. In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial. Hum Reprod. 2020 Nov 1;35(11):2537-2547. doi: 10.1093/humrep/deaa240.

  PMID: 32974672 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

• Preis KA, Seidel GE Jr, Gardner DK. Reduced oxygen concentration improves the developmental competence of mouse oocytes following in vitro maturation. Mol Reprod Dev. 2007 Jul;74(7):893-903. doi: 10.1002/mrd.20655.

  PMID: 17192892 BACKGROUND

• Akin N, Ates G, von Mengden L, Herta AC, Meriggioli C, Billooye K, Stocker WA, Ghesquiere B, Harrison CA, Cools W, Klamt F, Massie A, Smitz J, Anckaert E. Effects of lactate, super-GDF9, and low oxygen tension during bi-phasic in vitro maturation on the bioenergetic profiles of mouse cumulus-oocyte complexdagger. Biol Reprod. 2023 Oct 13;109(4):432-449. doi: 10.1093/biolre/ioad085.

  PMID: 37531262 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Tuong M Ho

  Mỹ Đức Hospital

  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: October 12, 2023
• First Posted: October 17, 2023
• Study Start: November 9, 2023
• Primary Completion: January 30, 2024
• Study Completion: May 22, 2024
• Last Updated: June 3, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)