CAPA-IVM Culture With Low Oxygen Tension

NCT06367985 | Completed DMC

• 1 other identifier: 03/24/DD-BVMD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology.

Conditions

In Vitro Fertilization

Keywords

CAPA-IVM; Low Oxygen Tension; Oxygen; Culture; PCOS

Outcome Measures

Primary Outcomes (1)

• Maturation rate

  The oocyte maturation rate was usually defined by MII oocyte number divided by total COCs number

  Two day after oocyte retrieval

Secondary Outcomes (46)

• Total number of oocytes retrieval

  On the day of oocyte retrieval

• Number of patients with no oocyte retrieved

  On the day of oocyte retrieval

• Number of MII oocytes

  Two day after oocyte retrieval

• Number of GV oocytes

  Two day after oocyte retrieval

• Number of patients with no matured oocyte

  Two day after oocyte retrieval

Study Arms (2)

Air Oxygen Concentration CAPA-IVM culture

EXPERIMENTAL

Half of the COCs will be cultured in the CAPA step and IVM step at 37 degrees Celsius in air oxygen concentration (20%) and 6% carbon dioxide.

Other: Air Oxygen Concentration CAPA-IVM culture

Low Oxygen Concentration CAPA-IVM culture

ACTIVE COMPARATOR

Half of the COCs will be cultured in the CAPA step at a low oxygen concentration (5%) and IVM step at an air oxygen concentration (20%); all two steps combine 6% carbon dioxide at 37 degrees Celsius.

Other: Low Oxygen Concentration CAPA-IVM culture

Interventions

Air Oxygen Concentration CAPA-IVM culture OTHER

* Group 1A: COC will be cultured in the CAPA step at an air oxygen concentration (20%) for 24 hours and 6% carbon dioxide at 37 degrees Celsius. * Group 1B: COCs will be cultured in the CAPA step at an air oxygen concentration (20%) for 24 hours and in the IVM step at an air oxygen concentration (20%) for 30 hours; all two steps combine 6% carbon dioxide at 37 degrees Celsius.

Air Oxygen Concentration CAPA-IVM culture

Low Oxygen Concentration CAPA-IVM culture OTHER

* Group 2A: COC will be cultured in the CAPA step at a low oxygen concentration (5%) for 24 hours and 6% carbon dioxide at 37 degrees Celsius. * Group 2B: COCs will be cultured in the CAPA step at a low oxygen concentration (5%) for 24 hours and the IVM step at an air oxygen concentration (20%) for 30 hours; all two steps combine 6% carbon dioxide at 37 degrees Celsius.

Low Oxygen Concentration CAPA-IVM culture

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Diagnosed with polycystic ovary syndrome according to the Rotterdam criteria (2003)
• Indicating CAPA-IVM treatment
• Having at least 40 antral follicles in two ovaries by transvaginal ultrasound at the time of CAPA-IVM indication
• Agreeing to have frozen embryo transfer
• Agreeing to participate in the trial

You may not qualify if:

• Cycles with oocyte donation, preimplantation Genetic Testing (PGT)
• Couples with severe male factor (sperm concentration \<5 million/ml, motility \< 10%), surgical sperm retrieval
• Previous history of unexplained immature oocytes after IVF treatment
• Uterine abnormalities

Sponsors & Collaborators

• Mỹ Đức Hospital: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (11)

• Practice Committees of the American Society for Reproductive Medicine, the Society of Reproductive Biologists and Technologists, and the Society for Assisted Reproductive Technology. Electronic address: jgoldstein@asrm.org. In vitro maturation: a committee opinion. Fertil Steril. 2021 Feb;115(2):298-304. doi: 10.1016/j.fertnstert.2020.11.018. Epub 2020 Dec 24.

  PMID: 33358333 BACKGROUND

• Paulson RJ, Fauser BCJM, Vuong LTN, Doody K. Can we modify assisted reproductive technology practice to broaden reproductive care access? Fertil Steril. 2016 May;105(5):1138-1143. doi: 10.1016/j.fertnstert.2016.03.013. Epub 2016 Apr 4.

  PMID: 27054309 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

• Gilchrist RB, Ho TM, De Vos M, Sanchez F, Romero S, Ledger WL, Anckaert E, Vuong LN, Smitz J. A fresh start for IVM: capacitating the oocyte for development using pre-IVM. Hum Reprod Update. 2024 Jan 3;30(1):3-25. doi: 10.1093/humupd/dmad023.

  PMID: 37639630 BACKGROUND

• Zhao X, Liu X, Feng Y, Shi D, Lu F. Regulation of hypoxia-inducible factor 1alpha by optimal oxygen concentration enhances oocyte maturation and early embryonic development in buffalo. Theriogenology. 2023 Aug;206:50-59. doi: 10.1016/j.theriogenology.2023.05.006. Epub 2023 May 8.

  PMID: 37187055 BACKGROUND

• Fischer B, Bavister BD. Oxygen tension in the oviduct and uterus of rhesus monkeys, hamsters and rabbits. J Reprod Fertil. 1993 Nov;99(2):673-9. doi: 10.1530/jrf.0.0990673.

  PMID: 8107053 BACKGROUND

• Bahrami M, Cottee PA. Culture conditions for in vitro maturation of oocytes - A review. Reproduction and Breeding. 2022 Jun 1;2(2):31-6

  BACKGROUND

• Increased susceptibility to oxidative stress as a proximate cost of reproduction - Alonso-Alvarez - 2004 - Ecology Letters - Wiley Online Library [Internet]. [cited 2023 Sep 19]. Available from: https://onlinelibrary.wiley.com/doi/10.1111/j.1461-0248.2004.00594.x

  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

• Herta AC, von Mengden L, Akin N, Billooye K, Coucke W, van Leersum J, Cava-Cami B, Saucedo-Cuevas L, Klamt F, Smitz J, Anckaert E. Characterization of carbohydrate metabolism in in vivo- and in vitro-grown and matured mouse antral folliclesdagger. Biol Reprod. 2022 Oct 11;107(4):998-1013. doi: 10.1093/biolre/ioac124.

  PMID: 35717588 BACKGROUND

• Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098.

  PMID: 14688154 BACKGROUND

Study Officials

• Lan N Vuong, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  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

Model Details: Sibling oocytes

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 16, 2024
• Study Start: May 13, 2024
• Primary Completion: July 11, 2024
• Study Completion: June 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

VN (1)