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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06087354
Other study ID # 11/23/DD-BVMD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2023
Est. completion date May 22, 2024

Study information

Verified date October 2023
Source M? Ð?c Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Oocyte in vitro maturation (IVM) is an alternative approach to assisted reproductive technology (ART) that has the advantage of minimal stimulation, resulting in reduced hormone-related side effects and risks, especially in women with polycystic ovary syndrome (PCOS). Oocytes retrieved for IVM procedures are derived from a diverse pool of follicles with an average diameter of between 2 and 10mm and are characterized by variable cellular and molecular attributes that indicate their immature status. Therefore, the development of an IVM culture system that could enable and enhance the acquisition and synchronization of meiotic and developmental competence prior to the meiotic resumption is essential for optimizing human IVM protocols. IVM with a pre-maturation step, known as capacitation IVM (CAPA-IVM), has been shown to improve the competence of human oocytes matured in vitro and result in live births. The pre-maturation culture of CAPA-IVM utilizes C-type natriuretic peptide (CNP), and maturation takes place in the presence of amphiregulin (AREG), both of which are physiological compounds that have been shown to prevent spontaneous meiotic resumption of oocytes (CNP) and enhance oocyte competence (AREG) during IVM. To date, the results of pilot studies have shown that CAPA-IVM increases the rates of oocyte maturation, good-quality embryos on day 3 and good-quality blastocysts, resulting in a result, a higher embryo yield was obtained compared with standard IVM. Additionally, the reported cumulative live birth rate after use of CAPA-IVM, and its non-inferiority to the cumulative live birth rate with standard in vitro fertilization highlight the clinical utility and potential of this approach. Improvements in the culture system could make CAPA-IVM more effective, but these need to be investigated. The oxygen concentration during the IVM process plays a crucial role in oocyte maturation. The use of oxygen concentrations higher than physiological levels can lead to cell damage and affect embryo development. Recent studies in mice have suggested using lower oxygen concentrations to improve IVM outcomes. However, the effectiveness of using lower oxygen concentrations in human IVM remains unproven. Therefore, this pilot study aims to compare the effectiveness of lower oxygen concentration conditions versus air oxygen in CAPA-IVM on embryology outcomes in PCOS women.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 22, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 37 Years
Eligibility Inclusion Criteria: - =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 Exclusion Criteria: - Cases with severe male factor (concentration <5 million/ml, cryptozoospermia, azoospermia) - Oocyte donation - Pre-implantation genetic testing

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Vietnam My Duc Hospital Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of blastocyst Number of blastocyst obtained At least 5 days after intra-cytoplasmic sperm injection
Secondary Number of matured oocytes Number of oocytes which have a polar body after maturation Two days after oocytes pick-up
Secondary Number of normal fertilized oocytes Number of oocytes which have 2 pronuclear 16-18 hours after intra-cytoplasmic sperm injection
Secondary Number of day-3 embryos Number of day-3 embryos obtained At least 3 days after intra-cytoplasmic sperm injection
Secondary Number of good-quality day-3 embryos Number of good quality Day 3 embryos obtained At least 3 days after intra-cytoplasmic sperm injection
Secondary Number of good-quality blastocyst Number of good quality blastocyst obtained At least 5 days after intra-cytoplasmic sperm injection
Secondary Number of vitrified blastocyst Number of vitrified blastocyst obtained At least 5 days after intra-cytoplasmic sperm injection
Secondary Positive pregnancy test Serum human chorionic gonadotropin level greater than 25 mIU/mL At 2 weeks after the completion of the first frozen embryo transfer
Secondary Clinical pregnancy At least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity 5 weeks after embryo placement after the completion of the first transfer
Secondary Ongoing pregnancy Defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer At 12 weeks' gestation
Secondary Implantation rate Defined as the number of gestational sacs per number of embryos transferred 3 weeks after embryo transferred after the completion of the first transfer
Secondary Multiple pregnancy Defined as presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation) 5 weeks after embryo placement after the completion of the first transfer
Secondary Miscarriage pregnancy loss at <12 weeks at 12 weeks of gestation after the completion of the first transfer
See also
  Status Clinical Trial Phase
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Terminated NCT05793931 - A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage
Completed NCT04297553 - Fresh Versus Freeze-only After CAPA IVM on PCOS Patients N/A
Recruiting NCT04774432 - Effect of GM-CSF on CAPA-IVM System Success Rates in PCOS N/A
Completed NCT04296357 - Health of IVF Versus IVM Children (FM-BABIES)
Completed NCT04488211 - IVM Survey Among Reproductive Medicine Specialists
Completed NCT03405701 - IVM Versus IVF in High Antral Follicle Count Patients N/A
Completed NCT04048486 - Children Born From IVM-CAPA vs IVF or Natural Conception
Completed NCT03915054 - Amphiregulin Versus Non-Amphiregulin Supplementation to Maturation Culturing Medium in IVM. N/A
Recruiting NCT06369415 - Health of Babies Born From IVF Versus IVM at 5 Years Old