IVF/ICSINCT05332769
Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality (FLIM)
An observational study of IVF/ICSI and Frozen Embryo Transfer, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IVF/ICSI, Frozen Embryo Transfer, Cumulus Cell
- What is being tested?
- FLIM parameters
- How many people
- 200 participants
- Where
- 1 siteVietnam
- Study dates
- 25 Apr 2022to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality
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.
Read the detailed description
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.
Participants will be consented to and pre-signed following standard regimens of IVFMD, My Duc Hospital and IVFMD PN, My Duc Phu Nhuan Hospital. The standard is for patients with at least 8 follicles ≥ 10 mm on ultrasonography at the induced ovulation date.
Cumulus samples (CCs) will be collected following the protocol on the day of oocyte pick up (OPU), being assigned with the same number as the oocyte from which it was collected, and vitrified with a Cryotech kit until FLIM measurements are performed.
Insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. A sample of CCs will be sliced off the cumulus mass of each oocyte judged to be mature based on the cumulus mass disposition (absence of tight corona layers). The remaining cumulus cells will be stripped from the OCCs using hyaluronidase. Only mature oocytes will be inseminated.
The fertilization check will be performed under an inverted microscope for a period of 16-18 hours after insemination. On day 3, embryo evaluation will be performed at a fixed time point 66±2 hours after fertilization and, for day 5/6 transfers at 116±2 hours or 140±2 hours, respectively, using the Istanbul consensus. Freeze-all strategy for day 5 embryo will be applied and the first frozen embryo transfer cycle is single embryo transfer.
On the other hand, the investigators will stratify embryos into two groups based on the measured FLIM parameters from their associated cumulus cells, corresponding to the "high" 35% and "low" 65% of metabolic scores.
The investigators aim for embryos in the "high" metabolic scoring group to have a 10% higher live birth rate than controls. Assuming a current live birth rate of 32%, this corresponds to a hoped-for 42% live birth rate in the "high" group (and a 25% live birth rate in the "low" group). A total of 450 patients are required to detect an effect of this size (power 0.90, two-sided alpha 5%).
The primary endpoint of the study will be the live birth rate after the first embryo transfer of the started treatment cycle.
- Being tested
- FLIM parameters
- Keywords
- Cumulus cell, Day 5/6 frozen embryo, Fluorescence lifetime imaging microscopy, FLIM, IVF/ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIM parametersGenetic
Also called fluorescence lifetime imaging microscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: FLIM parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 24 week's gestation
Secondary outcomes (4)
Positive pregnancy test
Positive pregnancy test is defined as a serum human chorionic gonadotropin level greater than 25 mIU/mL after2 weeks after embryo placement of the first transfer
Measured: At 2 weeks after embryo placement
Clinical pregnancy
The presence of at least one gestational sac on ultrasound at 7 week's gestation with the detection of heartbeat activity, after the completion of the first transfer
Measured: 7 week's gestation
Implantation rate
Implantation rate is defined as the number of gestational sacs per number of embryos transferred 3 weeks after the first transfer
Measured: 3 weeks after the first transfer
Ongoing pregnancy
Having at least 1 gestational sac on ultrasound at 12 weeks' gestation with heart beat activity
Measured: At 10 weeks after embryo placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start25 Apr 2022
- Primary completion30 May 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for IVF/ICSIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Needleman Lab, Northwest Lab Building 359,52 Oxford Street Cambridge MA 02138., Harvard University Faculty of Medicine, Hospital Foch, Suresnes, France.
- Responsible party
- Sponsor
- Investigators
- Tuong M Ho, MD, MCE, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332769
- Sponsor's protocol ID
- 11/21/DD/BVMD
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30593441Dumollard 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.
PubMed 17222699May-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.
PubMed 27562289Babayev E, Seli E. Oocyte mitochondrial function and reproduction. Curr Opin Obstet Gynecol. 2015 Jun;27(3):175-81. doi: 10.1097/GCO.0000000000000164.
PubMed 25719756Scott 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.
PubMed 29708901Chakraborty 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.
PubMed 26758390Becker 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.
PubMed 22621335Sanchez 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.
PubMed 30446247Sanchez 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.
PubMed 30691624
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality
- ClinicalTrials.gov ID
- NCT05332769
- Acronym / sponsor ID
- 11/21/DD/BVMD
- Keywords
- Cumulus cell, Day 5/6 frozen embryo, Fluorescence lifetime imaging microscopy, FLIM, IVF/ICSI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Collaborators
- The Needleman Lab, Northwest Lab Building 359,52 Oxford Street Cambridge MA 02138., Harvard University Faculty of Medicine, Hospital Foch, Suresnes, France.
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Participants will be consented to and pre-signed following standard regimens of IVFMD, My Duc Hospital and IVFMD PN, My Duc Phu Nhuan Hospital. The standard is for patients with at least 8 follicles ≥ 10 mm on ultrasonography at the induced ovulation date.
Cumulus samples (CCs) will be collected following the protocol on the day of oocyte pick up (OPU), being assigned with the same number as the oocyte from which it was collected, and vitrified with a Cryotech kit until FLIM measurements are performed.
Insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. A sample of CCs will be sliced off the cumulus mass of each oocyte judged to be mature based on the cumulus mass disposition (absence of tight corona layers). The remaining cumulus cells will be stripped from the OCCs using hyaluronidase. Only mature oocytes will be inseminated.
The fertilization check will be performed under an inverted microscope for a period of 16-18 hours after insemination. On day 3, embryo evaluation will be performed at a fixed time point 66±2 hours after fertilization and, for day 5/6 transfers at 116±2 hours or 140±2 hours, respectively, using the Istanbul consensus. Freeze-all strategy for day 5 embryo will be applied and the first frozen embryo transfer cycle is single embryo transfer.
On the other hand, the investigators will stratify embryos into two groups based on the measured FLIM parameters from their associated cumulus cells, corresponding to the "high" 35% and "low" 65% of metabolic scores.
The investigators aim for embryos in the "high" metabolic scoring group to have a 10% higher live birth rate than controls. Assuming a current live birth rate of 32%, this corresponds to a hoped-for 42% live birth rate in the "high" group (and a 25% live birth rate in the "low" group). A total of 450 patients are required to detect an effect of this size (power 0.90, two-sided alpha 5%).
The primary endpoint of the study will be the live birth rate after the first embryo transfer of the started treatment cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile women have IVF/ICSI cycle | – | Genetic: FLIM parametersAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLIM parametersAlso: fluorescence lifetime imaging microscopyCumulus 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. | Genetic | Infertile women have IVF/ICSI cycle |
Primary outcome
Live birth rate after one frozen embryo transfer cycle
Time frame: After 24 week's gestation
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
4 secondary outcomes
Positive pregnancy test
Time frame: At 2 weeks after embryo placement
Clinical pregnancy
Time frame: 7 week's gestation
Implantation rate
Time frame: 3 weeks after the first transfer
Ongoing pregnancy
Time frame: At 10 weeks after embryo placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Results publication: PubMed 30593441Fauser 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.
- Results publication: PubMed 17222699Dumollard 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.
- Results publication: PubMed 27562289May-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.
- Results publication: PubMed 25719756Babayev E, Seli E. Oocyte mitochondrial function and reproduction. Curr Opin Obstet Gynecol. 2015 Jun;27(3):175-81. doi: 10.1097/GCO.0000000000000164.
- Results publication: PubMed 29708901Scott 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.
- Results publication: PubMed 26758390Chakraborty 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.
- Results publication: PubMed 22621335Becker 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.
- Results publication: PubMed 30446247Sanchez 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.
- Results publication: PubMed 30691624Sanchez 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.
- T. H. F. and E. A. (HFEA), "Fertility treatment 2019: trends and figures," 2021.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho, MD, MCE principal investigator
Mỹ Đức Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF/ICSI and Frozen Embryo Transfer, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate after one frozen embryo transfer cycle (time frame: After 24 week's gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05332769, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.