InfertilityNCT02230449
Identifying Expression Markers of Cumulus Cells to Identify Oocyte Developmental Potential Through a Maturation Analysis
An observational study of Infertility, run by Memorial Sisli Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile couples applying to the clinic for assisted reproductive technologies
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Memorial Sisli Hospital ART Center
Istanbul, 34385
About this study
Official title: Identifying Markers of Oocyte Competence Through a Maturation Analysis
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.
Read the 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
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days
Secondary outcomes (1)
Implantation Rate
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sisli Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Semra Kahraman, Memorial Sisli Hospital, Istanbul
- Investigators
- Semra Kahraman, Prof. Dr, Study chair, Manager of ART and Genetics CenterSemra Kahraman, Prof. Dr., Study director, Manager of ART and Genetics CenterMehmet Ali Tufekci, PhD, Principal investigator, ART Center Research and Development Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230449
- Sponsor's protocol ID
- OocyteCompetenceSK001
- Other IDs
- GFI-2014-#21
- Status last verified
- Sep 2017
- First submitted
- 19 Aug 2014
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30031399
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Markers of Oocyte Competence Through a Maturation Analysis
- ClinicalTrials.gov ID
- NCT02230449
- Acronym / sponsor ID
- OocyteCompetenceSK001
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Memorial Sisli Hospital, IstanbulUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile couples applying to the clinic for assisted reproductive technologies
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulus cell RNA expression correlation with blastocyst formation potential and quality
Time frame: 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.
1 secondary outcome
Implantation Rate
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Derived from this study: PubMed 30031399Kahraman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semra Kahraman, Prof. Dr study chair
Manager of ART and Genetics Center
Semra Kahraman, Prof. Dr. study director
Manager of ART and Genetics Center
Mehmet Ali Tufekci, PhD principal investigator
ART Center Research and Development Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Memorial Sisli Hospital, Istanbul at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulus cell RNA expression correlation with blastocyst formation potential and quality (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02230449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.