Personalizing Window of Implantation During Frozen Embryo Transfer

NCT04840121 | Completed

• 1 other identifier: IIS - 1006
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of clinical pregnancy

  14 days after embryo transfer

Study Arms (2)

Study Group - AdhesioRT

ACTIVE COMPARATOR

Prior to frozen embryo transfer, participants will proceed with the AdhesioRT test. Participants randomized in the study group will proceed with frozen embryo transfer cycle according window of implantation determined by AdhesioRT.

Diagnostic Test: AdhesioRT

Control Group - Standard of Care

ACTIVE COMPARATOR

Prior to frozen embryo transfer, participants will proceed with the AdhesioRT test. Participants randomized in the control group will proceed with the first frozen embryo transfer cycle as per standard of care. In the event of unsuccessful implantation (negative serum pregnancy test), participants will proceed with subsequent frozen embryo transfer cycle according to window of implantation determined by AdhesioRT.

Diagnostic Test: AdhesioRT

Interventions

AdhesioRT DIAGNOSTIC_TEST

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

Control Group - Standard of Care; Study Group - AdhesioRT

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Study Officials

• Isaac-Jacques Kadoch, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in either the study group - AdhesioRT or in the control group - standard of care. All participants recruited, including the control group, will have the AdhesioRT biopsies performed.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: March 24, 2021
• Primary Completion: November 30, 2023
• Study Completion: January 29, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)