Personalizing Window of Implantation During Frozen Embryo Transfer (AdhesioRT)

Ovo Clinic

Status: Completed

Conditions: Fertility

Treatments: Diagnostic Test: AdhesioRT

Study type: Interventional

Funder types: Industry

Identifiers

NCT04840121

IIS - 1006

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Study Group - AdhesioRT

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: AdhesioRT

Control Group - Standard of Care

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: AdhesioRT