Aurora Test for ART Donor Patients (AURORA-Donor)

Infertility Clinical Trial

Official title:

An Observational Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Cumulus Cells of Women Treated With Human Recombinant FSH (Hr-FSH)and Triggered With GnRH Agonist in an Oocyte Donation Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280677
• Other study ID #: 2023.Aurora-Donor
• Status: Recruiting
• Start date: February 16, 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Fertiga, Belgium
• Contact: Tom Adriaenssens, PhD
• Phone: 024774645
• Email: tom.adriaenssens[@]fertiga.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Fertilab	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fertiga, Belgium	Ferring Pharmaceuticals, Fertilab

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ongoing pregnancy rate	The presence of gestational sacs with fetal heart beat detected by transvaginal ultrasound examination in gestational week 10 to 11	Week 10-11 after embryo transfer
Other	Live birth	is defined as the birth of at least one newborn after 24 weeks gestation that exhibits any sign of live (twins will be a single count)	week 24-42 after embryo transfer
Other	Cumulative pregnancy	The accumulated ongoing pregnancy after fresh and frozen-warmed embryo transfers within one stimulation cycle. Pregnancy with detectable heart rate at = 12 weeks gestation after the completion of the first transfer.; Live birth is defined as the birth of at least one newborn after 24 weeks gestation that exhibits any sign of live (twins will be a single count)	2.5 years after study start
Other	Cumulative live birth	The number of deliveries with at least one live birth resulting from one initiated or aspirated ART cycle, including all cycles in which fresh and/or frozen embryos are transferred, until one delivery with a live birth occurs or until all embryos are used, whichever occurs first.	2.5 years after study start
Other	Miscarriage rate	the spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age	week 22 after embryo transfer
Primary	Basic clinical donor patient and stimulation characteristics: P4	Serum values for P4 (ng/ml)	During ovarian stimulation (max 3 weeks)
Primary	Basic clinical donor patient and stimulation characteristics: E2	Serum values for E2 (ng/L)	During ovarian stimulation (max 3 weeks)
Primary	Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose	Gonadotropin type and dose (IU) used for stimulation	During ovarian stimulation (max 3 weeks)
Primary	Clinical evaluation: number of Follicles	The number of follicles at time of trigger (oocyte-pick-up day-2)	During ovarian stimulation (max 3 weeks)
Primary	Clinical evaluation: number of cumulus-oocyte complex	The number of cumulus-oocyte complex at time of pick-up	Day 1 of embryo culture
Primary	Clinical evaluation: Meiosis II oocytes	The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)	Day 1 of embryo culture
Primary	Clinical evaluation: Abnormal fertilization	The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated	Day 1 of embryo culture
Primary	Clinical evaluation: Normal Fertilization	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	Day 1 of embryo culture
Primary	Clinical evaluation: Day 3 embryo evaluation	Day 3 embryo morphology evaluation according to the standard of care of the ART clinic	Day 3 of embryo culture
Primary	Clinical evaluation: Day 5/6 embryo evaluation	Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)	Day 6 of embryo culture
Primary	Clinical evaluation: Day5/6 good quality blastocyst rate	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)	Day 6 of embryo culture
Primary	Clinical evaluation: Embryo utilization	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)	Day 6 of embryo culture
Primary	Expression profile: blastocyst formation	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.	2.5 years after study start
Secondary	Biochemical pregnancy	A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine	Day 10 after embryo transfer
Secondary	Clinical pregnancy with positive fetal heartbeat	Pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat in gestational week 6 to 8	week 5-6 after embryo transfer
Secondary	Expression profile: pregnancy prediction	The expression profile of cumulus of oocytes leading to pregnancy and the expression profiles of oocytes not leading to pregnancy are established using RNA seq.	2.5 years after study start
Secondary	Normalized messenger ribonucleic acid (mRNA) expression	Quantitative Polymerase Chain Reaction (QPCR) data of samples informative for blastocyst formation and pregnancy prediction have been collected	2.5 years after study start