InfertilityPréSynUT-1NCT02328742
Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
An observational study of Infertility and Abortion, Spontaneous, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Infertility, Abortion, Spontaneous, Embryo Implantation, Delayed
- What is being tested?
- Hysteroscopy + endometrial biopsy, Telephone call and Resection + endometrial biopsy
- How many people
- 0 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2015to May 2018
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of women of childbearing age (≥18 years and <45 years) requiring a hysteroscopy motivated by an infertility evaluation, failure of embryo implantation after invitro fertilization, repeated miscarriages
Who may be able to join
- The patient must be given free and informed consent and must have signed the consent form
- The patient must be affiliated with or beneficiary of a health insurance plan
- Indication for hysteroscopy associated with one of the following: infertility evaluation, postoperative dysmenorrhea, embryo implantation failure after invitro fertilization, recurrent miscarriages
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, guardianship or curatorship
- The patient refuses to sign the consent
- It is not possible to correctly inform the patient
- The patient is postmenopausal
- Indication of hysteroscopy not associated with exploration of infertility or dysmenorrhea
- Presence of endometritis objectified via sampling during diagnostic hysteroscopy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut des Biomolécules Max Mousseron
Montpellier, 34093
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
Official title: Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary disease.
Read the detailed description
The secondary obectives are:
- For women who are found to have synechia or another intracavitary pathology at the time of resection: To describe the levels of Transforming growth factor beta, Activin A and Inhibin involved in synechia at the time of resection.
- For women who are found to have synechia or another intracavitary pathology at the time of resection:To describe the levels of Transforming growth factor beta, Activin A and Inhibin involved in synechia at the time of a follow-up hysteroscopy following resection.
- For women who are found to have synechia at the time of resection:To describe the change in levels of Transforming growth factor beta, Activin A and Inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts back to "no synechia".
- For women who are found to have another intracavitary pathology at the time of resection: To describe the change in levels of Transforming growth factor beta, Activin A and Inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts to "synechia".
- To estimate the intra-individual variation in the measured factors (initial biopsy levels versus levels at time of resection).
- To create an intrauterine map of factor levels according to biopy position (riosteal / medium / proximal) for patients with synechia or another intracavitary pathology at the time of resection and then follow-up hysteroscopy.
- To describe the levels of Transforming growth factor beta, Activin A and Inhibin as a function of pregnancy 6 months after resection.
- Create a tissue bank associated with the study.
- Being tested
- Hysteroscopy + endometrial biopsy, Telephone call, Resection + endometrial biopsy, Follow-up hysteroscopy + endometrial biopsy
- Medical subject headings
- Infertility, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopy + endometrial biopsyBiological
The day of the first diagnostic hysteroscopy an endometrial biopsy is performed (biopsy A1). These biopsies will be used for the evaluation of TGFbeta, Activin A and inhibin.
This intervention is required for the observational needs of this study.
Telephone callOther
Patients will be contacted via telephone 6 months after first hysteroscopy.
This intervention is required for the observational needs of this study.
Resection + endometrial biopsyBiological
If patients are found to have synechia or another intracavitary pathology, resection is scheduled 1-2 months later. A second endometrial biopsy is performed at this time.
This intervention is required for the observational needs of this study.
Follow-up hysteroscopy + endometrial biopsyBiological
For patients having had resection, a follow-up hysteroscopy is performed 1 to 3 months later. An endometrial biopsy will be performed at this time.
This intervention is required for the observational needs of this study.
| Study group | Role | What they receive |
|---|---|---|
| No intracavitary pathology | During the first diagnostic hysteroscopy, patients in this group are found to not have an intracavitary pathology. (The first 20 such patients will be retained in this group.)
Intervention: Hysteroscopy + endometrial biopsy
Intervention: Telephone call Receives: Biological: Hysteroscopy + endometrial biopsy; Other: Telephone call | |
| Synechia | During the first diagnostic hysteroscopy, patients in this group are found to have synechia.
Intervention: Hysteroscopy + endometrial biopsy
Intervention: Resection + endometrial biopsy
Intervention: Follow-up hysteroscopy + endometrial biopsy
Intervention: Telephone call Receives: Biological: Hysteroscopy + endometrial biopsy; Other: Telephone call; Biological: Resection + endometrial biopsy; Biological: Follow-up hysteroscopy + endometrial biopsy | |
| Intracavitary pathology | During the first diagnostic hysteroscopy, patients in this group are found to have an intracavitary pathology.
Intervention: Hysteroscopy + endometrial biopsy
Intervention: Resection + endometrial biopsy
Intervention: Follow-up hysteroscopy + endometrial biopsy
Intervention: Telephone call Receives: Biological: Hysteroscopy + endometrial biopsy; Other: Telephone call; Biological: Resection + endometrial biopsy; Biological: Follow-up hysteroscopy + endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activin A
Measured: Day 0 (day of diagnostic hysteroscopy)
Inhibin
Measured: Day 0 (day of diagnostic hysteroscopy)
Transforming growth factor beta
Measured: Day 0 (day of diagnostic hysteroscopy)
Diagnosis of synechia or other intracavitary pathology
Measured: Day 0 (day of diagnostic hysteroscopy)
Secondary outcomes (9)
Activin A
Measured: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Inhibin
Measured: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Transforming growth factor beta
Measured: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Diagnosis of synechia or other intracavitary pathology
Measured: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Activin A
Measured: 1 to 3 months after resection (day of follow-up hysteroscopy)
Inhibin
Measured: 1 to 3 months after resection (day of follow-up hysteroscopy)
Transforming growth factor beta
Measured: 1 to 3 months after resection (day of follow-up hysteroscopy)
Diagnosis of synechia or other intracavitary pathology
Measured: 1 to 3 months after resection (day of follow-up hysteroscopy)
Pregnancy (yes/no)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Feasibility issues require solutions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Letouzey, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328742
- Sponsor's protocol ID
- LOCAL/2013/VL-03
- Other IDs
- 2014-A00837-40
- Acronym
- PréSynUT-1
- Status last verified
- Jan 2017
- First submitted
- 26 Dec 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
- ClinicalTrials.gov ID
- NCT02328742
- Acronym / sponsor ID
- PréSynUT-1 / LOCAL/2013/VL-03
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Feasibility issues require solutions.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- 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.
The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary disease.
Detailed description
The secondary obectives are:
- For women who are found to have synechia or another intracavitary pathology at the time of resection: To describe the levels of Transforming growth factor beta, Activin A and Inhibin involved in synechia at the time of resection.
- For women who are found to have synechia or another intracavitary pathology at the time of resection:To describe the levels of Transforming growth factor beta, Activin A and Inhibin involved in synechia at the time of a follow-up hysteroscopy following resection.
- For women who are found to have synechia at the time of resection:To describe the change in levels of Transforming growth factor beta, Activin A and Inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts back to "no synechia".
- For women who are found to have another intracavitary pathology at the time of resection: To describe the change in levels of Transforming growth factor beta, Activin A and Inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts to "synechia".
- To estimate the intra-individual variation in the measured factors (initial biopsy levels versus levels at time of resection).
- To create an intrauterine map of factor levels according to biopy position (riosteal / medium / proximal) for patients with synechia or another intracavitary pathology at the time of resection and then follow-up hysteroscopy.
- To describe the levels of Transforming growth factor beta, Activin A and Inhibin as a function of pregnancy 6 months after resection.
- Create a tissue bank associated with the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intracavitary pathology | – | Biological: Hysteroscopy + endometrial biopsy, Other: Telephone callDuring the first diagnostic hysteroscopy, patients in this group are found to not have an intracavitary pathology. (The first 20 such patients will be retained in this group.) Intervention: Hysteroscopy + endometrial biopsy Intervention: Telephone call |
| Synechia | – | Biological: Hysteroscopy + endometrial biopsy, Other: Telephone call, Biological: Resection + endometrial biopsy, Biological: Follow-up hysteroscopy + endometrial biopsyDuring the first diagnostic hysteroscopy, patients in this group are found to have synechia. Intervention: Hysteroscopy + endometrial biopsy Intervention: Resection + endometrial biopsy Intervention: Follow-up hysteroscopy + endometrial biopsy Intervention: Telephone call |
| Intracavitary pathology | – | Biological: Hysteroscopy + endometrial biopsy, Other: Telephone call, Biological: Resection + endometrial biopsy, Biological: Follow-up hysteroscopy + endometrial biopsyDuring the first diagnostic hysteroscopy, patients in this group are found to have an intracavitary pathology. Intervention: Hysteroscopy + endometrial biopsy Intervention: Resection + endometrial biopsy Intervention: Follow-up hysteroscopy + endometrial biopsy Intervention: Telephone call |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of women of childbearing age (≥18 years and <45 years) requiring a hysteroscopy motivated by an infertility evaluation, failure of embryo implantation after invitro fertilization, repeated miscarriages
Key inclusion criteria (3 listed)
- The patient must be given free and informed consent and must have signed the consent form
- The patient must be affiliated with or beneficiary of a health insurance plan
- Indication for hysteroscopy associated with one of the following: infertility evaluation, postoperative dysmenorrhea, embryo implantation failure after invitro fertilization, recurrent miscarriages
Key exclusion criteria (8 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, guardianship or curatorship
- The patient refuses to sign the consent
- It is not possible to correctly inform the patient
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 |
|---|---|---|
| Hysteroscopy + endometrial biopsyThe day of the first diagnostic hysteroscopy an endometrial biopsy is performed (biopsy A1). These biopsies will be used for the evaluation of TGFbeta, Activin A and inhibin. This intervention is required for the observational needs of this study. | Biological | Intracavitary pathology, No intracavitary pathology, Synechia |
| Telephone callPatients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study. | Other | Intracavitary pathology, No intracavitary pathology, Synechia |
| Resection + endometrial biopsyIf patients are found to have synechia or another intracavitary pathology, resection is scheduled 1-2 months later. A second endometrial biopsy is performed at this time. This intervention is required for the observational needs of this study. | Biological | Intracavitary pathology, Synechia |
| Follow-up hysteroscopy + endometrial biopsyFor patients having had resection, a follow-up hysteroscopy is performed 1 to 3 months later. An endometrial biopsy will be performed at this time. This intervention is required for the observational needs of this study. | Biological | Intracavitary pathology, Synechia |
Primary outcome
Activin A
Time frame: Day 0 (day of diagnostic hysteroscopy)
Inhibin
Time frame: Day 0 (day of diagnostic hysteroscopy)
Transforming growth factor beta
Time frame: Day 0 (day of diagnostic hysteroscopy)
Diagnosis of synechia or other intracavitary pathology
Time frame: Day 0 (day of diagnostic hysteroscopy)
9 secondary outcomes
Activin A
Time frame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Inhibin
Time frame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Transforming growth factor beta
Time frame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Diagnosis of synechia or other intracavitary pathology
Time frame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
Activin A
Time frame: 1 to 3 months after resection (day of follow-up hysteroscopy)
Inhibin
Time frame: 1 to 3 months after resection (day of follow-up hysteroscopy)
Transforming growth factor beta
Time frame: 1 to 3 months after resection (day of follow-up hysteroscopy)
Diagnosis of synechia or other intracavitary pathology
Time frame: 1 to 3 months after resection (day of follow-up hysteroscopy)
Pregnancy (yes/no)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
Vincent Letouzey, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Abortion, Spontaneous, run by Centre Hospitalier Universitaire de Nīmes at 3 sites 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Activin A (time frame: Day 0 (day of diagnostic hysteroscopy)). The study lists 4 primary outcomes in all. 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 1 Feb 2017.