InfertileWin-TestNCT04192396
Prospective Study of an Human Endometrial Receptivity Test
An observational study of Infertile, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Evaluation of endometrial receptivity is a crucial step in in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) programs. Using "Omic technologies", such as transcriptomic and proteomic analyses, the investigators previously identified a specific molecular signature of human endometrial receptivity… Read more about this study
- Who is it for?
- Ages 27 to 48 years, women only
- Conditions the study is for
- Infertile
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2012to 25 May 2019
- Phase
- Observational
- 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 27 to 48 years
- Women only
- No healthy volunteers
- Adult
Study population: Women were recruited after written informed consent. All of them had a severe history of repeated implantation failures (RIFs). A classical infertility evaluation was performed including transvaginal sonography and uterine cavity was assessed by hysteroscopy. All patients were scheduled for replacement of cryopreserved embryos under hormone replacement therapy (HRT) or natural cycle. A mock frozen embryo transfer cycle, using a natural cycle or a HRT protocol, was monitored. Patients had endometrial biopsies performed through the presumed implantation window, 6 to 9 days after the LH (luteinizing hormone) surge for those on natural cycle or 5 to 9 days after the progesterone administration under HRT. Each biopsy was assessed for endometrial receptivity status using the Win-Test and assessment was stopped when appropriate endometrial receptivity was found. The clinical suitability of the Win-Test was performed in RIF patients who subsequently received Win-Test's guided embryo transfer.
Who may be able to join
- Infertile patients associated with multiple implantation failures.
- Signatures consent and non-opposition letter.
- Patients with a standard infertility assessment.
- Patients with a monitored cycle (ultrasound, hormonal markers) during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle.
- Patients with complete treatment information during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle.
- Patients with accurate transfer day information.
- Patients for whom we have the outcome (pregnancy, live birth).
Who cannot join
- More than 24 weeks of amenorrhea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of the 'Win Test', a New Diagnostic Tool to Assess Human Endometrial Receptivity Under Natural Cycle or Hormone Replacement Therapy
Evaluation of endometrial receptivity is a crucial step in in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) programs. Using "Omic technologies", such as transcriptomic and proteomic analyses, the investigators previously identified a specific molecular signature of human endometrial receptivity during the embryo implantation window. After validation of this signature in fertile women and in an ex vivo model (i.e., stromal and epithelial endometrium cells),the investigatorsdeveloped a diagnostic tool called Win-Test (Window Implantation Test) to evaluate the expression level of a set of endometrial receptivity-specific genes during the implantation window by quantitative RT-PCR. Based on their expression, each endometrial biopsy sample can be classified as receptive, partially receptive or non-receptive. Then, after the identification of the right cycle day within the implantation window where endometrium is considered as receptive, a customized timing for embryo transfer with respect of the synchronization of the embryo-maternal dialogue must be performed. A prospective study to validate the relevance of the Win-Test, is a necessary step to gauge its effectiveness. In this objective, patients with multiple implantation failures will be recruited. Embryo transfers were performed in double-arm: the intervention group had a customized timing of embryo transfer according to the Win-Test strategy and recommendation, the control group had their embryos transferred in a classical timing. Pregnancy and live birth rates (LBR) were compared between groups.
- Conditions
- Infertile
- Keywords
- Endometrial receptivity assessment for customized embryo transfer, Human Reproduction, ART, Endometrial receptivity
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RIF patients | Repeated implantation failure patients | |
| Oocyte/embryo donation program | Patients awaiting for oocyte/embryo-donation recipient patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy was defined as ultrasound visualization of a gestational sac with a positive embryo heartbeat
Measured: At 7-8 weeks of amenorrhea after customized timing of embryo transfer
Secondary outcomes (1)
Live birth rate
Live birth rate was defined as a delivery with at least one live born baby of more than 24 weeks of amenorrhea
Measured: More than 24 weeks of amenorrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jul 2012
- Primary completion1 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertileStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono (GFI)
- Responsible party
- Sponsor
- Investigators
- Samir Hamamah, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192396
- Sponsor's protocol ID
- RECHMPL19_0590
- Acronym
- Win-Test
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Haouzi D, Entezami F, Torre A, Innocenti C, Antoine Y, Mauries C, Vincens C, Bringer-Deutsch S, Gala A, Ferrieres-Hoa A, Ohl J, Gonzalez Marti B, Brouillet S, Hamamah S. Customized Frozen Embryo Transfer after Identification of the Receptivity Window with a Transcriptomic Approach Improves the Implantation and Live Birth Rates in Patients with Repeated Implantation Failure. Reprod Sci. 2021 Jan;28(1):69-78. doi: 10.1007/s43032-020-00252-0. Epub 2020 Jul 28.
PubMed 32725589
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the 'Win Test', a New Diagnostic Tool to Assess Human Endometrial Receptivity Under Natural Cycle or Hormone Replacement Therapy
- ClinicalTrials.gov ID
- NCT04192396
- Acronym / sponsor ID
- Win-Test / RECHMPL19_0590
- Conditions
- Infertile
- Keywords
- Endometrial receptivity assessment for customized embryo transfer, Human Reproduction, ART, Endometrial receptivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Merck Serono (GFI)
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 10 Dec 2019 (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.
Evaluation of endometrial receptivity is a crucial step in in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) programs. Using "Omic technologies", such as transcriptomic and proteomic analyses, the investigators previously identified a specific molecular signature of human endometrial receptivity during the embryo implantation window. After validation of this signature in fertile women and in an ex vivo model (i.e., stromal and epithelial endometrium cells),the investigatorsdeveloped a diagnostic tool called Win-Test (Window Implantation Test) to evaluate the expression level of a set of endometrial receptivity-specific genes during the implantation window by quantitative RT-PCR. Based on their expression, each endometrial biopsy sample can be classified as receptive, partially receptive or non-receptive. Then, after the identification of the right cycle day within the implantation window where endometrium is considered as receptive, a customized timing for embryo transfer with respect of the synchronization of the embryo-maternal dialogue must be performed. A prospective study to validate the relevance of the Win-Test, is a necessary step to gauge its effectiveness. In this objective, patients with multiple implantation failures will be recruited. Embryo transfers were performed in double-arm: the intervention group had a customized timing of embryo transfer according to the Win-Test strategy and recommendation, the control group had their embryos transferred in a classical timing. Pregnancy and live birth rates (LBR) were compared between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIF patients | – | –Repeated implantation failure patients |
| Oocyte/embryo donation program | – | –Patients awaiting for oocyte/embryo-donation recipient patients |
Who may qualify
- Ages
- 27 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women were recruited after written informed consent. All of them had a severe history of repeated implantation failures (RIFs). A classical infertility evaluation was performed including transvaginal sonography and uterine cavity was assessed by hysteroscopy. All patients were scheduled for replacement of cryopreserved embryos under hormone replacement therapy (HRT) or natural cycle. A mock frozen embryo transfer cycle, using a natural cycle or a HRT protocol, was monitored. Patients had endometrial biopsies performed through the presumed implantation window, 6 to 9 days after the LH (luteinizing hormone) surge for those on natural cycle or 5 to 9 days after the progesterone administration under HRT. Each biopsy was assessed for endometrial receptivity status using the Win-Test and assessment was stopped when appropriate endometrial receptivity was found. The clinical suitability of the Win-Test was performed in RIF patients who subsequently received Win-Test's guided embryo transfer.
Key inclusion criteria (7 listed)
- Infertile patients associated with multiple implantation failures.
- Signatures consent and non-opposition letter.
- Patients with a standard infertility assessment.
- Patients with a monitored cycle (ultrasound, hormonal markers) during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle.
- Patients with complete treatment information during the mock frozen embryo transfer cycle to perform the Win-test and during the embryo transfer cycle.
Key exclusion criteria (1 listed)
- More than 24 weeks of amenorrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical pregnancy rate
Time frame: At 7-8 weeks of amenorrhea after customized timing of embryo transfer
Clinical pregnancy was defined as ultrasound visualization of a gestational sac with a positive embryo heartbeat
1 secondary outcome
Live birth rate
Time frame: More than 24 weeks of amenorrhea
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 11 Dec 2019.
- Derived from this study: PubMed 32725589Haouzi D, Entezami F, Torre A, Innocenti C, Antoine Y, Mauries C, Vincens C, Bringer-Deutsch S, Gala A, Ferrieres-Hoa A, Ohl J, Gonzalez Marti B, Brouillet S, Hamamah S. Customized Frozen Embryo Transfer after Identification of the Receptivity Window with a Transcriptomic Approach Improves the Implantation and Live Birth Rates in Patients with Repeated Implantation Failure. Reprod Sci. 2021 Jan;28(1):69-78. doi: 10.1007/s43032-020-00252-0. Epub 2020 Jul 28.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Infertile
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Samir Hamamah principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertile, run by University Hospital, Montpellier at 1 site in France.
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 7 inclusion and 1 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 11 Dec 2019. 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 France. 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?
Clinical pregnancy rate (time frame: At 7-8 weeks of amenorrhea after customized timing of embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192396, which also lists 1 linked publication.
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 11 Dec 2019.