Infertility Clinical Trial
— PréSynUT-1Official title:
Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
Verified date | January 2017 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | |
France | Institut des Biomolécules Max Mousseron | Montpellier Cedex 05 | |
France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Activin A | Day 0 (day of diagnostic hysteroscopy) | ||
Primary | Inhibin | Day 0 (day of diagnostic hysteroscopy) | ||
Primary | Transforming growth factor beta | Day 0 (day of diagnostic hysteroscopy) | ||
Primary | Diagnosis of synechia or other intracavitary pathology | Day 0 (day of diagnostic hysteroscopy) | ||
Secondary | Activin A | 1 to 2 months after diagnostic hysteroscopy (day of resection) | ||
Secondary | Inhibin | 1 to 2 months after diagnostic hysteroscopy (day of resection) | ||
Secondary | Transforming growth factor beta | 1 to 2 months after diagnostic hysteroscopy (day of resection) | ||
Secondary | Diagnosis of synechia or other intracavitary pathology | 1 to 2 months after diagnostic hysteroscopy (day of resection) | ||
Secondary | Activin A | 1 to 3 months after resection (day of follow-up hysteroscopy) | ||
Secondary | Inhibin | 1 to 3 months after resection (day of follow-up hysteroscopy) | ||
Secondary | Transforming growth factor beta | 1 to 3 months after resection (day of follow-up hysteroscopy) | ||
Secondary | Diagnosis of synechia or other intracavitary pathology | 1 to 3 months after resection (day of follow-up hysteroscopy) | ||
Secondary | Pregnancy (yes/no) | 6 months |
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