AURORA-Donor: Explorative study of cumulus cells gene expression in relation to the oocyte competence for good quality blastocyst formation and predictive for clinical pregnancy.
Study summary
This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria Donor:
* Patients are 18 to 35 years old
* BMI between 17-30
* Regular menstrual cycles
* AFC \> 8
* Patient profile in compliance with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)
* Patients' stimulation: GnRH Antagonist \& hr-FSH with GnRH Agonist trigger or Progesterone \& hr-FSH with GnRH Agonist trigger
* Patients agree that the oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study
Exclusion Criteria Donor:
* BMI \< 17 or \> 30
* Extreme irregular menstrual cycles (\<20 days or \>40 days)
* AFC \< 8
* \<8 MII on previous egg retrieval
* Women with history of poor oocyte maturation or known maturation defect or unexplained failure in previous treatments
* Patients that fail to comply with SEF (Sociedad Española de Fertilidad) directives for egg donation (medical, psychological and genetic screening, informed consent)
Inclusion Criteria Recipient:
* Patients applying for ART egg donation with fresh/frozen sperm from the partner or frozen donor sperm. With eSB-FET in modified natural cycle or an HRT cycle.
* Patients are from 18 to 50 years old.
* Patients will be treated by ICSI (intracytoplasmic sperm injection) and eSB-FET (elective Single Blastocyst Frozen Embryo Transfer)
* Recipient patients agree that the donors' oocytes will be denuded for cumulus testing and provide written informed consent for participation to the study
Exclusion Criteria for oocyte Recipients
* Patient included in any other prospective study.
* BMI \< 17 or \> 35
* Severe uterine factor: Multiple myomectomy, multiple fibroids, major uterine malformation (unicorn, septum), Asherman Sd, severe adenomyosis
* Repeated Implantation Failure or Repeated Pregnancy Loss after euploid Single Blastocyst Transfer
* Severe male factor: Abnormal Caryotype or FISH, severe OAT / Cripto-Azoospermia, DNA Fragmentation \>50% after medical treatment
* TESE / TESA (testicular sperm extraction/aspiration)
Primary outcome measure(s)
Basic clinical donor patient and stimulation characteristics: P4 — During ovarian stimulation (max 3 weeks) Serum values for P4 (ng/ml)
Basic clinical donor patient and stimulation characteristics: E2 — During ovarian stimulation (max 3 weeks) Serum values for E2 (ng/L)
Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose — During ovarian stimulation (max 3 weeks) Gonadotropin type and dose (IU) used for stimulation
Clinical evaluation: number of Follicles — During ovarian stimulation (max 3 weeks) The number of follicles at time of trigger (oocyte-pick-up day-2)
Clinical evaluation: number of cumulus-oocyte complex — Day 1 of embryo culture The number of cumulus-oocyte complex at time of pick-up
Clinical evaluation: Meiosis II oocytes — Day 1 of embryo culture The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Clinical evaluation: Abnormal fertilization — Day 1 of embryo culture The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated
Clinical evaluation: Normal Fertilization — Day 1 of embryo culture The number of fertilized oocytes on day 1 (presence of 2PN and 2PB assessed at 17 + 1h post-insemination), as a function of all COC's inseminate
Clinical evaluation: Day 3 embryo evaluation — Day 3 of embryo culture Day 3 embryo morphology evaluation according to the standard of care of the ART clinic
Clinical evaluation: Day 5/6 embryo evaluation — Day 6 of embryo culture Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)
Clinical evaluation: Day5/6 good quality blastocyst rate — Day 6 of embryo culture Defined as the proportion of 2PN zygotes which are good-quality blastocyst on Day 5/6 (116 +-2h and 140 +-2h post-insemination) (ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine 2017)
Clinical evaluation: Embryo utilization — Day 6 of embryo culture Defined as the number of blastocyst suitable for cryopreservation and transfer as a function of the number of normally fertilized (2PN) oocytes observed on day 1 (ESHRE Special Interest Group Alpha Scientists 2017)
Expression profile: blastocyst formation — 2.5 years after study start The expression profiles of cumulus of oocyte leading to a blastocyst and the expression profiles of cumulus of oocyte not leading to a blastocyst has been determined using RNA-Seq.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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