FertilityAdhesioRTNCT04840121
Personalizing Window of Implantation During Frozen Embryo Transfer
A study testing AdhesioRT in people with Fertility, run by Clinique Ovo at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fertility
- What is being tested?
- AdhesioRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2021to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: ADHESIORT - Personalizing Window of Implantation During Frozen Embryo Transfer
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
- Being tested
- AdhesioRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdhesioRTDiagnostic test
AdhesioRT, a novel diagnostic genetic assay, developed by ovo R\&D scientists, helps to predict the endometrial receptivity and embryo implantation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: AdhesioRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days after embryo transfer
Secondary outcomes (1)
Rate of clinical pregnancy
Blood test to determine if the embryo transfer was successful or not
Measured: 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start24 Mar 2021
- Primary completion30 Nov 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Isaac-Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840121
- Sponsor's protocol ID
- IIS - 1006
- Acronym
- AdhesioRT
- Status last verified
- Feb 2024
- First submitted
- 6 Apr 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHESIORT - Personalizing Window of Implantation During Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT04840121
- Acronym / sponsor ID
- AdhesioRT / IIS - 1006
- Conditions
- Fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group - AdhesioRT | Active comparator | Diagnostic Test: AdhesioRTPrior 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. |
| Control Group - Standard of Care | Active comparator | Diagnostic Test: AdhesioRTPrior 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdhesioRTAdhesioRT, a novel diagnostic genetic assay, developed by ovo R\&D scientists, helps to predict the endometrial receptivity and embryo implantation. | Diagnostic test | Control Group - Standard of Care, Study Group - AdhesioRT |
Primary outcome
Determination of appropriate window of implantation
Time frame: 14 days after embryo transfer
Comparison between standard frozen embryo transfer and personalized frozen embryo transfer using AdhesioRT to determine a successful window of implantation
1 secondary outcome
Rate of clinical pregnancy
Time frame: 14 days after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac-Jacques Kadoch, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AdhesioRT in people with Fertility, run by Clinique Ovo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of appropriate window of implantation (time frame: 14 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.