Personalizing Window of Implantation During Frozen Embryo Transfer

Fertility Clinical Trial

— AdhesioRT  

Official title:

ADHESIORT - Personalizing Window of Implantation During Frozen Embryo Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840121
• Other study ID #: IIS - 1006
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: January 29, 2024

Study information

• Verified date: February 2024
• Source: Clinique Ovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Embryo implantation is a crucial event in the establishment of a pregnancy. Although the clinical and culture conditions to obtain a "good quality" embryo are well advanced today, endometrial receptivity remains a major barrier in assisted reproductive techniques. Once a high-quality embryo is transferred, impaired uterine receptivity is believed to be one of the major reasons behind failure of the establishment of pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 29, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women between the ages of 18 to 40 inclusive at the time of oocyte retrieval

• Prescription of a single frozen embryo transfer - substituted cycle protocol

• Participant has at least 2 vitrified good quality blastocysts

Exclusion Criteria:

• Women undergoing fertility preservation

• Stage IV severe endometriosis

• Severe malformation, adenomyosis or uterine anomaly including fibroids deforming the uterine cavity = 5 cm

• Positive results of screening for either participant or partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C

Related Conditions & MeSH terms

• Fertility

Intervention

Diagnostic Test:
• AdhesioRT
AdhesioRT, a novel diagnostic genetic assay, developed by ovo R&D scientists, helps to predict the endometrial receptivity and embryo implantation.

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Ovo	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of appropriate window of implantation	Comparison between standard frozen embryo transfer and personalized frozen embryo transfer using AdhesioRT to determine a successful window of implantation	14 days after embryo transfer
Secondary	Rate of clinical pregnancy	Blood test to determine if the embryo transfer was successful or not	14 days after embryo transfer