Aurora Test for Patients Treated With Recombinant Gonadotropins

Infertility Clinical Trial

— AURORA-REC  

Official title:

An Observational Cohort Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Ovarian Cumulus Cells From Patients Treated by Intracytoplasmic Sperm Injection (ICSI) That Are Treated With Recombinant Gonadotropins

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04710264
• Other study ID #: 2020.Aurora-Rec
• Status: Active, not recruiting
• Start date: February 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Fertiga, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study. The main aim is to determine the expression of potential biomarker genes in the cumulus cells isolated from individual oocytes in two patient cohorts: recombinant human Follicle Stimulating Hormone(hFSH) and recombinant hFSH:human Luteinizing Hormone(r-hLH) ratio 2:1. Algorithms from gene combinations will be identified that predict embryo quality and pregnancy outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Est. completion date: December 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 38 Years

Eligibility

Inclusion Criteria:

• Patients are between 22-38 years old

• BMI between 17-33

• provide written informed consent

• Patients undergoing a first or second ICSI treatment cycle.

• Patients will be treated by ICSI (intracytoplasmic sperm injection)

• Patients agree that the oocytes will be denuded for cumulus testing and agree to the single blastocyst transfer.

• Patients must be predicted good ovarian responders (AMH 1-4,7 ng/ml) with 7-18 follicles of minimum 10-11 mm on trigger day (oocyte retrieval minus 2 days (OR -2)) by ultrasound following ovarian stimulation with r-hFSH or r-hFSH with r-hLH in a Gonadotropin-releasing hormone (GnRH) antagonist protocol (starting dose recombinant Follicle Stimulating Hormone (rFSH) between 150-225 IU)

• HCG trigger after stimulation (r-hCG)

Exclusion Criteria:

• Women with less than 7 or more than 18 follicles at Day -2 or -3 measured by ultrasound

• Women with history of poor oocyte maturation or known maturation defect

• Irregular menstrual cycle (< 24 or > 35 days)

• BMI < 17 or > 33

• Smoking > 10 cigarettes per day.

• Known low ovarian response based on Bologna criteria

• Combined use of urinary and recombinant gonadotropins in the current cycle

• Patients with severe endometriosis = III (AFS classification)

• Polycystic ovary syndrome (PCOS), defined by revised criteria American Society for Reproductive Medicine (ASRM) European Society of Human Reproduction and Embryology (ESHRE) 2018

• Patient included in any other study

• Patient scheduled for preimplantation genetic testing (PGT)

• Testicular sperm extraction (TESE) or extreme oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml.

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• AURORA-Rec
Explorative study of cumulus cells gene expression in relation to the patient treatment and oocyte competence.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette

Sponsors (2)

Lead Sponsor	Collaborator
Fertiga, Belgium	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative ongoing pregnancy rate	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	3 years after study start
Other	Live Birth rate	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 Live Birth rate	The number of deliveries with at least one live birth resulting from one initiated or aspirated artificial reproductive technologies (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.	3 years after study start
Primary	Normalized messenger ribonucleic acid (mRNA) expression	Normalized mRNA levels of biomarker genes that are assessed in cumulus cells by reverse transcription quantitative Polymerase Chain Reaction (RT-qPCR) for each oocyte.	3 years after study start
Secondary	Meiosis II Oocyte rate	The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)	Day 0 of embryo collection
Secondary	Normal fertilization rate	The number of fertilized oocytes on Day 1 (presence of 2 pronuclei (2PN) and the second polar body (2PB) assessed at 17 ± 1 h postinsemination, as a function of all cumulus-oocytes complexes (COCs) inseminated	Day 1 of embryo culture
Secondary	Day 5 good-quality embryo rate	Defined as the proportion of 2PN zygotes which are good-quality blastocysts on Day 5	Day 5 of embryo culture
Secondary	Embryo utilization rate	Defined as the number of embryos (or blastocysts) suitable for transfer or cryopreservation as a function of the number of normally fertilized (2PN) oocytes observed on Day 1	Day 5 of embryo culture
Secondary	Biochemical pregnancy rate	A pregnancy diagnosed only by the detection of beta human chorionic gonadotropin (hCG) in serum or urine	Day 10 after embryo transfer
Secondary	Fetal heart beat positive implantation rate	Rate refers to the proportion of fetal heartbeats detected relative to the number of embryos transferred	Week 5-6 after embryo transfer
Secondary	Clinical pregnancy rate	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	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
Secondary	Miscarriage rate	The spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age. In this study we capture spontaneous miscarriage till gestational week 12.	Week 12 after embryo transfer