NCT05332769

Brief Summary

This study aims to test the extent of association of FLIM parameters of cumulus cells with clinical outcomes (clinical pregnancy, ongoing pregnancy at 12 weeks, and live birth) of the embryos that result from the enclosed oocytes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Apr 2022Dec 2026

First Submitted

Initial submission to the registry

April 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

April 10, 2022

Last Update Submit

March 17, 2026

Conditions

IVF/ICSIFrozen Embryo TransferCumulus CellFluorescence Lifetime Imaging Microscopy

Keywords

Cumulus cellDay 5/6 frozen embryoFluorescence lifetime imaging microscopyFLIMIVF/ICSI

Outcome Measures

Primary Outcomes (1)

  • Live birth rate after one frozen embryo transfer cycle

    The birth of at least one newborn, after 24 week's gestation that exhibits any sign of life, such as respiration, heartbeat, umbilical pulsation, or movement of voluntary muscles

    After 24 week's gestation

Secondary Outcomes (4)

  • Positive pregnancy test

    At 2 weeks after embryo placement

  • Clinical pregnancy

    7 week's gestation

  • Implantation rate

    3 weeks after the first transfer

  • Ongoing pregnancy

    At 10 weeks after embryo placement

Study Arms (1)

Infertile women have IVF/ICSI cycle

All Vietnamese infertile women who have IVF/ICSI cycle with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date agreed to freeze-all day 5-6 embryos at IVFMD and IVFMD PN will be enrolled in the study.

Genetic: FLIM parameters

Interventions

FLIM parametersGENETIC

Cumulus samples (CCs) will be collected following the protocol on the day of oocyte pick up (OPU). CCs are frozen by the cryo-tech method, then stored in liquid nitrogen at -196oC. Information of CC samples and processed date/time is recorded. After all, samples are collected, they will be transferred to The Needleman Lab, Northwest Lab Building 359,52 Oxford Street Cambridge MA 02138 to measure mitochondria metabolism using FLIM.

Also known as: fluorescence lifetime imaging microscopy
Infertile women have IVF/ICSI cycle

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Vietnamese infertile women who have IVF/ICSI cycle with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date agreed to freeze-all day 5-6 embryos at IVFMD and IVFMD PN will be enrolled in the study.

You may qualify if:

  • Having any number of IVF/ICSI attempts
  • Ovarian stimulation with any stimulation protocol
  • Patients with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date
  • Agreed to freeze-all day 5-6 embryos
  • Agreed to have a single day 5-6 embryo transfer.
  • Agreed to participate in the research (signed the consent form)

You may not qualify if:

  • In vitro maturation (IVM) cycles
  • Cycles using testicular biopsy or epididymal sperm
  • Cycles not having an oocyte freeze-all cycle
  • Cycles using standard insemination
  • Participating in another research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (9)

  • Fauser BC. Towards the global coverage of a unified registry of IVF outcomes. Reprod Biomed Online. 2019 Feb;38(2):133-137. doi: 10.1016/j.rbmo.2018.12.001. Epub 2018 Dec 14. No abstract available.

    PMID: 30593441RESULT

  • Dumollard R, Duchen M, Carroll J. The role of mitochondrial function in the oocyte and embryo. Curr Top Dev Biol. 2007;77:21-49. doi: 10.1016/S0070-2153(06)77002-8.

    PMID: 17222699RESULT

  • May-Panloup P, Boucret L, Chao de la Barca JM, Desquiret-Dumas V, Ferre-L'Hotellier V, Moriniere C, Descamps P, Procaccio V, Reynier P. Ovarian ageing: the role of mitochondria in oocytes and follicles. Hum Reprod Update. 2016 Nov;22(6):725-743. doi: 10.1093/humupd/dmw028. Epub 2016 Aug 25.

    PMID: 27562289RESULT

  • Babayev E, Seli E. Oocyte mitochondrial function and reproduction. Curr Opin Obstet Gynecol. 2015 Jun;27(3):175-81. doi: 10.1097/GCO.0000000000000164.

    PMID: 25719756RESULT

  • Scott R 3rd, Zhang M, Seli E. Metabolism of the oocyte and the preimplantation embryo: implications for assisted reproduction. Curr Opin Obstet Gynecol. 2018 Jun;30(3):163-170. doi: 10.1097/GCO.0000000000000455.

    PMID: 29708901RESULT

  • Chakraborty S, Nian FS, Tsai JW, Karmenyan A, Chiou A. Quantification of the Metabolic State in Cell-Model of Parkinson's Disease by Fluorescence Lifetime Imaging Microscopy. Sci Rep. 2016 Jan 13;6:19145. doi: 10.1038/srep19145.

    PMID: 26758390RESULT

  • Becker W. Fluorescence lifetime imaging--techniques and applications. J Microsc. 2012 Aug;247(2):119-36. doi: 10.1111/j.1365-2818.2012.03618.x. Epub 2012 May 24.

    PMID: 22621335RESULT

  • Sanchez T, Wang T, Pedro MV, Zhang M, Esencan E, Sakkas D, Needleman D, Seli E. Metabolic imaging with the use of fluorescence lifetime imaging microscopy (FLIM) accurately detects mitochondrial dysfunction in mouse oocytes. Fertil Steril. 2018 Dec;110(7):1387-1397. doi: 10.1016/j.fertnstert.2018.07.022. Epub 2018 Nov 14.

    PMID: 30446247RESULT

  • Sanchez T, Zhang M, Needleman D, Seli E. Metabolic imaging via fluorescence lifetime imaging microscopy for egg and embryo assessment. Fertil Steril. 2019 Feb;111(2):212-218. doi: 10.1016/j.fertnstert.2018.12.014.

    PMID: 30691624RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Cumulus cell of oocyte

Study Officials

  • Tuong M Ho, MD, MCE

    Mỹ Đức Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2022

First Posted

April 18, 2022

Study Start

April 25, 2022

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

VN(1)