Single-center Prospective Cumulus Cell Test Study in rFSH Patients

Infertility Clinical Trial

Official title:

Cumulus Cell mRNA Analysis as Oocyte Quality Marker in the Fertility Lab in a Prospective Single-center Study for rFSH Stimulated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03663868
• Other study ID #: BUN143201318000 b
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: August 2021

Study information

• Verified date: August 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: Inge Van Vaerenbergh, PhD
• Phone: +32 2 477 46 45
• Email: inge.vanvaerenbergh[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Performing an additional non-invasive oocyte diagnostic test based on cumulus cell gene expression could improve the outcome of the ART cycle for rFSH stimulated patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2021
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

Inclusion Criteria:

• scheduled for intracytoplasmatic sperm injection (ICSI) and single (or double) embryo transfer on day 3

• patients down regulated with gonadotropin-releasing hormone (GnRH) antagonist and stimulated with recombinant Follicle Stimulating Hormone (FSH)

• undergoing first or second IVF or ICSI cycle with transfer

• Body Mass Index (BMI) between 17 and 33

• regular menstrual cycle (between 24 and 35 days)

Exclusion Criteria:

• smokers (> 10 cigarettes per day)

• patients requesting Pre-implantation Genetic Diagnosis (PGD)

• patients with polycystic ovary syndrome (PCOS), or severe endometriosis (AFS stage 3-4)

• couples where the partner has an extremely low sperm count i.e.: extreme oligo-astheno-teratozoospermia (OAT) (< 100.000/ml) or scheduled for testicular sperm extraction (TESE)

• results of eventual preceding cycles may not indicate a known genetic disease, or low ovarian response or an oocyte maturation defect

Related Conditions & MeSH terms

• Infertility

Intervention

Diagnostic Test:
• CC-Test
Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy as observed by ultrasound	This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database	2 months after embryo transfer
Secondary	Positive beta-hCG pregnancy as observed by serum analysis	This observation is routinely performed by the treating physician for every patient undergoing standard ART treatment and is thus available from the fertility center database	12-17 days after embryo transfer
Secondary	Live birth by questionnaire	This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database. This measurement does not include a scale, there is either a child born or not. The date of delivery and the gender of the child are asked together with eventual complications.	at least 9 months after embryo transfer
Secondary	Cumulative pregnancy by ultrasound (for pregnancy follow-up) and questionnaire (for live birth follow-up) (see outcome 1 and 3)	This is the compilation of the data gathered in outcome 1 and 3 for eventual consecutive cycles. This observation is routinely performed by the study nurses of the fertility center for every patient undergoing standard ART treatment and is thus available from the fertility center database	2 years after embryo transfer