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

NCT ID: NCT02230449

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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:

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

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sisli Hospital, Istanbul

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Semra Kahraman

Director of ART and Genetics Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semra Kahraman, Prof. Dr

Role: STUDY_CHAIR

Manager of ART and Genetics Center

Semra Kahraman, Prof. Dr.

Role: STUDY_DIRECTOR

Manager of ART and Genetics Center

Mehmet Ali Tufekci, PhD

Role: PRINCIPAL_INVESTIGATOR

ART Center Research and Development Department

Locations

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Memorial Sisli Hospital ART Center

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 30031399 (View on PubMed)

Other Identifiers

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GFI-2014-#21

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OocyteCompetenceSK001

Identifier Type: -

Identifier Source: org_study_id

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