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PCOS (Polycystic Ovary Syndrome)NCT07197255

Transcriptomic Profiling of Cumulus Cells From CAPA-IVM

An observational study of PCOS (Polycystic Ovary Syndrome) and Cumulus Cell, run by Mỹ Đức Hospital at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Capacitation in vitro maturation (CAPA-IVM) has improved oocyte maturation and resulted in live births. Because cumulus cells (CCs) communicate bidirectionally with the oocyte, their transcriptomic profile may serve as a non-invasive biomarker of oocyte and embryo competence. Read more about this study

Who is it for?
Ages 18 to 38 years, women only
How many people
10 participants
Where
1 siteVietnam
Study dates
16 Oct 2025to 30 Mar 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 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women with PCOS diagnosed according to the Rotterdam 2003 criteria who are indicated for CAPA-IVM treatment at IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.

Who may be able to join

  • Women 18-38 years
  • BMI =< 32kg/m2
  • Diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam 2003 criteria, meet at least 2 of the following 3 features: (1) Oligo-ovulation or anovulation. (2) Clinical and/or biochemical signs of hyperandrogenism (3) Polycystic ovarian morphology on ultrasound.
  • Indicated for CAPA-IVM treatment.
  • Serum AMH ≥ 4 ng/mL (28.57 pmol/L).
  • Antral follicle count (AFC) ≥ 24 follicles in both ovaries at the time of CAPA-IVM indication.
  • Signed informed consent to participate in the study.

Who cannot join

  • Retrieved sperm from surgical procedures
  • Previous IVF cycle with total immature oocytes

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huy H Pham, MSc. contact

+84966145510

huy.ph@myduchospital.vn

Vietnam1 site, 1 recruiting

  • My Duc Hospital

    Ho Chi Minh City

    Tuong M Ho, MD, +84903633377, tuongho.ivfmd@gmail.com

    Lan N Vuong, MD, PhD, +84903008889, drlan@yahoo.com.vn

    Recruiting

Other trials in Vietnam

About this study

Official title: Transcriptomic Profiling of Cumulus Cells From CAPA-IVM Cycles in Women With PCOS: A Prospective Pilot Study

Capacitation in vitro maturation (CAPA-IVM) has improved oocyte maturation and resulted in live births. Because cumulus cells (CCs) communicate bidirectionally with the oocyte, their transcriptomic profile may serve as a non-invasive biomarker of oocyte and embryo competence. This prospective pilot study will analyze CCs gene expression after CAPA-IVM using RNA sequencing and pathway analysis, and correlate findings with embryological outcomes including fertilization, day-3 cleavage, and blastocyst formation. Results are expected to provide insights into the molecular basis of oocyte competence and support development of non-invasive embryo selection strategies.

Read the detailed description

In vitro maturation (IVM) is an alternative to conventional ovarian stimulation, particularly for women with polycystic ovary syndrome (PCOS) or at risk of ovarian hyperstimulation syndrome (OHSS). A novel technique, known as capacitation IVM (CAPA-IVM), introduces a pre-maturation step that improves both nuclear and cytoplasmic maturation and has been associated with live births. Cumulus-oocyte complexes (COCs) represent the functional unit of oocyte competence, with cumulus cells (CCs) providing bidirectional signaling that regulates oocyte development. Because CCs are routinely removed during ICSI, they serve as a readily accessible and non-invasive source of information about oocyte and embryo potential.

This prospective observational cohort study will be conducted at the IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam. Eligible participants are women diagnosed with PCOS according to the Rotterdam 2003 criteria, with serum AMH ≥ 4 ng/mL and antral follicle count (AFC) ≥ 24, indicated for CAPA-IVM treatment. From each participant, 15 COCs will be allocated to single-culture CAPA-IVM condition. CCs from each COC will be collected for transcriptomic analysis, while the oocytes are assessed for embryological outcomes. The remaining COCs will follow the standard CAPA-IVM protocol at the center.

RNA sequencing will be performed using low-input protocols. Data will undergo differential expression analysis (DESeq2), and functional interpretation using Gene Ontology and Ingenuity Pathway Analysis. Laboratory outcomes including day-3 cleavage, and blastocyst formation will be correlated with CC transcriptomic profiles. This study aims to identify non-invasive biomarkers of oocyte and embryo competence, supporting future embryo selection strategies in assisted reproduction. By correlating cumulus cell transcriptomic profiles with oocyte and embryo outcomes, this study seeks to establish preliminary non-invasive biomarkers for embryo selection in assisted reproduction.

Keywords
In vitro maturation, CAPA-IVM, Cumulus cells, Transcriptomics
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07197255
Study groupRoleWhat they receive
PCOS Women Undergoing CAPA-IVMWomen aged 18-38 years with PCOS (Rotterdam criteria) indicated for CAPA-IVM. From each participant, 15 cumulus-oocyte complexes (COCs) are allocated to single-culture CAPA-IVM. Cumulus cells from these COCs are collected at oocyte denudation for RNA sequencing and transcriptomic analysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of cumulus cell transcriptomic profiles with embryological outcomes

    Association between cumulus cell gene expression (RNA-seq-based transcriptomic profiles) and embryological outcomes, including cleavage and embryo quality (Day 3), and blastocyst formation and grading (Days 5-6).

    Measured: Through study completion, an average of 1 year

Secondary outcomes (8)

  1. CCs transcriptomic profiles

    RNA sequencing of CCs collected from individual COCs after CAPA-IVM. Differential gene expression will be analyzed using DESeq2, followed by Gene Ontology enrichment and Ingenuity Pathway Analysis to identify pathways, molecular functions, and regulatory networks associated with oocyte competence.

    Measured: Through study completion, an average of 1 year

  2. Number of matured oocyte

    The number of oocytes that have first polar body after denudation

    Measured: At day 2 after the Oocyte Pick-Up day

  3. Number of normal fertilized oocytes

    Oocytes that show the presence of two pronuclei

    Measured: 16-18 hours after intracytoplasmic sperm injection

  4. Number of day-3 embryos

    Day-3 embryo morphology assessed according to the Istanbul Consensus (2011), with reference to the revised criteria (2024)

    Measured: 68 ±1 hours after intra-cytoplasmic sperm injection

  5. Number of good-quality day-3 embryos

    Day-3 embryo morphology assessed according to the Istanbul Consensus (2011), with reference to the revised criteria (2024)

    Measured: 68±1 hours after intra-cytoplasmic sperm injection

  6. Number of blastocyst

    Blastocyst quality assessed on Day 5/6 according to the Istanbul Consensus (2011), with reference to the revised criteria (2024).

    Measured: Day 5 (116 ± 2 hours) and Day 6 (140 ± 2 hours) after intra-cytoplasmic sperm injection

  7. Number of good-quality blastocyst

    Good-quality blastocysts defined and graded according to the Istanbul Consensus (2011), with reference to the revised criteria (2024).

    Measured: Day 5 (116 ± 2 hours) and Day 6 (140 ± 2 hours) after intracytoplasmic sperm injection

  8. Number of frozen embryos

    Embryos that meet morphology and developmental criteria for cryopreservation by vitrification

    Measured: At the time of embryo cryopreservation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start16 Oct 2025
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion30 Mar 2026 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07197255
Sponsor's protocol ID
09/25/DD-BVMD
Status last verified
Nov 2025
First submitted
2 Sep 2025
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 14688154

  • Working Group on the update of the ESHRE/ALPHA Istanbul Consensus; Coticchio G, Ahlstrom A, Arroyo G, Balaban B, Campbell A, De Los Santos MJ, Ebner T, Gardner DK, Kovacic B, Lundin K, Magli MC, Mcheik S, Morbeck DE, Rienzi L, Sfontouris I, Vermeulen N, Alikani M. The Istanbul consensus update: a revised ESHRE/ALPHA consensus on oocyte and embryo static and dynamic morphological assessmentdagger,double dagger. Hum Reprod. 2025 Jun 1;40(6):989-1035. doi: 10.1093/humrep/deaf021.

    PubMed 40288770

  • Russell DL, Gilchrist RB, Brown HM, Thompson JG. Bidirectional communication between cumulus cells and the oocyte: Old hands and new players? Theriogenology. 2016 Jul 1;86(1):62-8. doi: 10.1016/j.theriogenology.2016.04.019. Epub 2016 Apr 21.

    PubMed 27160446

  • Assou S, Haouzi D, Mahmoud K, Aouacheria A, Guillemin Y, Pantesco V, Reme T, Dechaud H, De Vos J, Hamamah S. A non-invasive test for assessing embryo potential by gene expression profiles of human cumulus cells: a proof of concept study. Mol Hum Reprod. 2008 Dec;14(12):711-9. doi: 10.1093/molehr/gan067. Epub 2008 Nov 21.

    PubMed 19028806

  • Gebhardt KM, Feil DK, Dunning KR, Lane M, Russell DL. Human cumulus cell gene expression as a biomarker of pregnancy outcome after single embryo transfer. Fertil Steril. 2011 Jul;96(1):47-52.e2. doi: 10.1016/j.fertnstert.2011.04.033. Epub 2011 May 14.

    PubMed 21575950

  • Pham HH, Le AH, Nguyen TC, Ma MPQ, Akin N, Pham TD, Nguyen MHN, Le HL, Huynh BG, Smitz J, Ho TM, Vuong LN. Effect of single versus grouped culture of human cumulus-oocyte complexes in PCOS women treated with biphasic in vitro maturation: A sibling oocyte pilot study. Reprod Med Biol. 2024 Jun 7;23(1):e12587. doi: 10.1002/rmb2.12587. eCollection 2024 Jan-Dec.

    PubMed 38854775

  • Akin N, Richani D, Liao X, Zhao Y, Herta AC, Billooye K, Stocker WA, Mottershead DG, Harrison CA, Smitz J, Anckaert E, Gilchrist RB. Effect of cumulin and super-GDF9 in standard and biphasic mouse IVM. J Assist Reprod Genet. 2022 Jan;39(1):127-140. doi: 10.1007/s10815-021-02382-z. Epub 2022 Jan 4.

    PubMed 34984599

  • 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.

    PubMed 32974672

  • Sanchez F, Lolicato F, Romero S, De Vos M, Van Ranst H, Verheyen G, Anckaert E, Smitz JEJ. An improved IVM method for cumulus-oocyte complexes from small follicles in polycystic ovary syndrome patients enhances oocyte competence and embryo yield. Hum Reprod. 2017 Oct 1;32(10):2056-2068. doi: 10.1093/humrep/dex262.

    PubMed 28938744

Questions about this trial

What is this clinical trial studying?

An observational study of PCOS (Polycystic Ovary Syndrome) and Cumulus Cell, 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. 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?

Contact Huy H Pham, MSc. (+84966145510, huy.ph@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of cumulus cell transcriptomic profiles with embryological outcomes (time frame: Through study completion, an average of 1 year). 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 NCT07197255, 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 21 Nov 2025.

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