Personalizing Window of Implantation During Frozen Embryo Transfer

Study Overview
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Brief Summary
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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.

Official Title
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ADHESIORT - Personalizing Window of Implantation During Frozen Embryo Transfer

Conditions
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Fertility

Intervention / Treatment
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* Diagnostic Test: AdhesioRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group - AdhesioRT<br>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<br>* AdhesioRT, a novel diagnostic genetic assay, developed by ovo R&D scientists, helps to predict the endometrial receptivity and embryo implantation.<br>|
| Active Comparator: Control Group - Standard of Care<br>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<br>* AdhesioRT, a novel diagnostic genetic assay, developed by ovo R&D scientists, helps to predict the endometrial receptivity and embryo implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical pregnancy | Blood test to determine if the embryo transfer was successful or not | 14 days after embryo transfer |