Infertility Clinical Trial
Official title:
Identifying Markers of Oocyte Competence Through a Maturation Analysis
Verified date | September 2017 |
Source | Memorial Sisli Hospital, Istanbul |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Memorial Sisli Hospital ART Center | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Memorial Sisli Hospital, Istanbul |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 2 months |
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