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Identifying Expression Markers of Cumulus Cells to Identify Oocyte Developmental Potential Through a Maturation Analysis

Sponsor
Memorial Sisli Hospital, Istanbul (Other)
Overall Status
Completed
CT.gov ID
NCT02230449
Collaborator
(none)
200
Enrollment
1
Location
25
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In ART, one of the major obstacles encountered in some patients is the wide variation in the follicular size at the oocyte pick-up day and consequently, the number of available mature oocytes and the number of competent embryos for implantation. The follicular size at the day of oocyte pick-up reflects the synchronicity of the individual follicular responsiveness to FSH.

    For successful preimplantation development of an embryo, the oocyte must contain all necessary maternal factors. Two of these factors are specific mRNA transcripts (GDF9, PTX3, HAS2, PTGS2, TNFAIP6) and microRNA (miR-224).

    For each Cumulus Oocyte Complex, the evaluation of embryo development and morphokinetics will be correlated with the expression and implantation data to identify a quantitative biomarker to predict the embryo with the highest chance of implantation in patients.

    Experimental Design:
      • Collection of Cumulus Oocyte Complex (COC) from patients
      • Separation of oocytes according to the size of the follicule they have been retrieved from (<17mm; ≥17mm)
      • Isolation of mRNA from both groups of cumulus cells
      • Expression studies, qRT-PCR (GDF9, PTX3, HAS2, PTGS2, TNFAIP6)
      • Analysis of miR-224, a negative regulator of cumulus expansion via PTX3
      • Time-lapse culture & evaluation of morphokinetics

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identifying Markers of Oocyte Competence Through a Maturation Analysis
    Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2016
    Actual Study Completion Date :
    Sep 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Cumulus cell RNA expression correlation with blastocyst formation potential and quality [6 days]

      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.

    Secondary Outcome Measures

    1. Implantation Rate [2 months]

      Implantation of the embryo(s) transferred will be checked by ultrasound 6 weeks after the pick-up. Patients for whom the number of embryo(s) transferred match the number of sac will allow the correlation of the expression data with implantation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sisli Hospital ART Center Istanbul Turkey 34385

    Sponsors and Collaborators

    • Memorial Sisli Hospital, Istanbul

    Investigators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. Semra Kahraman, Director of ART and Genetics Center, Memorial Sisli Hospital, Istanbul
    ClinicalTrials.gov Identifier:
    NCT02230449
    Other Study ID Numbers:
    • OocyteCompetenceSK001
    • GFI-2014-#21
    First Posted:
    Sep 3, 2014
    Last Update Posted:
    Sep 5, 2017
    Last Verified:
    Sep 1, 2017
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Sep 5, 2017