Transcriptomic Profiling of Cumulus Cells From CAPA-IVM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-38
SponsorMỹ Đức Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Retrieved sperm from surgical procedures
Previous IVF cycle with total immature oocytes
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10 Participants
are grouped into 1 trial groupGroup A: PCOS Women Undergoing CAPA-IVM
Trial outcomes
Primary outcomes
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).
Time frame
Through study completion, an average of 1 yearSecondary outcomes
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.
Time frame
Through study completion, an average of 1 year2
Number of matured oocyte
The number of oocytes that have first polar body after denudation
Time frame
At day 2 after the Oocyte Pick-Up day3
Number of normal fertilized oocytes
Oocytes that show the presence of two pronuclei
Time frame
16-18 hours after intracytoplasmic sperm injection4
Number of day-3 embryos
Day-3 embryo morphology assessed according to the Istanbul Consensus (2011), with reference to the revised criteria (2024)
Time frame
68 ±1 hours after intra-cytoplasmic sperm injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mỹ Đức Hospital
Lead sponsor
Vrije Universiteit Brussel
Collaborator
Source ClinicalTrials.gov