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| Name | Class |
|---|---|
| Vrije Universiteit Brussel | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCOS Women Undergoing CAPA-IVM | Women 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huy H Pham, MSc. | Contact | +84966145510 | huy.ph@myduchospital.vn |
| Name | Affiliation | Role |
|---|---|---|
| Lan N Vương, PhD, MD | University of Medicine and Pharmacy at Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| My Duc Hospital | Recruiting | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14688154 | 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. | |
| 40288770 | Background | 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. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Cumulus cells collected from cumulus-oocyte complexes after CAPA-IVM for transcriptomic analysis (RNA-seq).
| Number of matured oocyte | The number of oocytes that have first polar body after denudation | At day 2 after the Oocyte Pick-Up day |
| Number of normal fertilized oocytes | Oocytes that show the presence of two pronuclei | 16-18 hours after intracytoplasmic sperm injection |
| Number of day-3 embryos | Day-3 embryo morphology assessed according to the Istanbul Consensus (2011), with reference to the revised criteria (2024) | 68 ±1 hours after intra-cytoplasmic sperm injection |
| 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) | 68±1 hours after intra-cytoplasmic sperm injection |
| Number of blastocyst | Blastocyst quality assessed on Day 5/6 according to the Istanbul Consensus (2011), with reference to the revised criteria (2024). | Day 5 (116 ± 2 hours) and Day 6 (140 ± 2 hours) after intra-cytoplasmic sperm injection |
| Number of good-quality blastocyst | Good-quality blastocysts defined and graded according to the Istanbul Consensus (2011), with reference to the revised criteria (2024). | Day 5 (116 ± 2 hours) and Day 6 (140 ± 2 hours) after intracytoplasmic sperm injection |
| Number of frozen embryos | Embryos that meet morphology and developmental criteria for cryopreservation by vitrification | At the time of embryo cryopreservation |
| 27160446 | Background | 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. |
| 19028806 | Background | 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. |
| 21575950 | Background | 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. |
| 38854775 | Background | 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. |
| 34984599 | Background | 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. |
| 32974672 | 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. |
| 28938744 | Background | 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. |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |