Identifying Expression Markers of Cumulus Cells to Identify Oocyte Developmental Potential Through a Maturation Analysis
Identifying Markers of Oocyte Competence Through a Maturation Analysis
2 other identifiers
observational
200
1 country
1
Brief Summary
The aim of the study is to analyze the expression of genes and microRNAs potentially involved in oocyte competence in follicles of different sizes (\<17mm and ≥17mm) at the time of oocyte pick-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 5, 2017
September 1, 2017
1.8 years
August 19, 2014
September 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulus cell RNA expression correlation with blastocyst formation potential and quality
At the day of oocyte pick-up, cumulus cells will be collected from each cumulus oocyte complex. RNA extraction will be performed from those cumulus cells and expression levels of 5 genes and 1 miRNA will be measured (compared with that of a housekeeping gene). Oocytes of those samples will be injected and cultured with routine Assisted Reproduction Techniques. At the day 5 \& 6, after the oocyte pick-up procedure, each blastocyst formed will be noted and the quality of each blastocyst will be recorded. The blastocyst grading will be done according to Gardner's blastocyst morphological criteria (degree of expansion of the blastocoele cavity: 1 to 5, inner cell mass morphology: A to C, trophectoderm morphology: A to C). The composite primary outcome measure will allow the correlation of the expression levels of 5 genes and 1 miRNA of each cumulus oocyte complex with the corresponding embryo morphology on day 5 (presence or absence of a blastocyst) and blastocyst quality.
6 days
Secondary Outcomes (1)
Implantation Rate
2 months
Eligibility Criteria
Infertile couples applying to the clinic for assisted reproductive technologies
You may qualify if:
- No more than 2 previous treatment cycles
- No history of recurrent spontaneous abortions
- Age ≤ 39 years
- BMI \< 30 kg / m2
- ≥ 8 cumulus-oocyte-complexes (COC) retrieved
- human Chorionic Gonadotrophin (hCG) triggering
You may not qualify if:
- Preimplantaion Genetic Diagnosis (PGD) or Preimplantation Genetics Screening (PGS) indication
- Maximum number of 24 COC during pickup
- Failure to culture until Day 5
- Polycystic ovary syndrome
- Severe endometrial factor that can influence implantation
- Uterine malformation or congenital anomaly
- Severe male factor (Azoospermia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sisli Hospital ART Center
Istanbul, 34385, Turkey (Türkiye)
Related Publications (1)
Kahraman S, Cetinkaya CP, Cetinkaya M, Tufekci MA, Ekmekci CG, Montag M. Is there a correlation between follicle size and gene expression in cumulus cells and is gene expression an indicator of embryo development? Reprod Biol Endocrinol. 2018 Jul 21;16(1):69. doi: 10.1186/s12958-018-0388-0.
PMID: 30031399DERIVED
Biospecimen
Cumulus cells from each oocyte of every enrolled patient will be collected and mRNA \& miRNA extraction will be performed.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Semra Kahraman, Prof. Dr
Manager of ART and Genetics Center
- STUDY DIRECTOR
Semra Kahraman, Prof. Dr.
Manager of ART and Genetics Center
- PRINCIPAL INVESTIGATOR
Mehmet Ali Tufekci, PhD
ART Center Research and Development Department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of ART and Genetics Center
Study Record Dates
First Submitted
August 19, 2014
First Posted
September 3, 2014
Study Start
August 1, 2014
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
September 5, 2017
Record last verified: 2017-09