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Patient care in Medically Assisted Procreation (MAP) requires a close and regular monitoring of the evolution of the estradiol rate. This monitoring allows the dose and duration of treatment to be accurately adjusted for each woman (every 24 or 48 hours) up to 10 to 15 days of treatment with gonadotrophins. Oestradiol (E2) is secreted by the growing ovarian follicles and reflects their growth and maturity. Its plasma dosage makes it possible to monitor the ovarian response to stimulation.
This monitoring involves several constraints amongst which disruption of work life, stress, fatigue that can alter the response to treatment
In order to improve the comfort of patients already under severe stress, simplification of this monitoring is proposed. The development of an immediate-release whole blood test for simplified monitoring of estradiol levels will provide considerable comfort in the management of patients. These patients are subjected to significant emotional and physical stress and the development of this test will reduce the negative consequences that result.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with ovarian stimulation | Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dosage of oestradiol | Diagnostic Test | The study is based on a concept using capillary blood tests using lateral flow by migration on membrane similarly to a pregnancy test, patented by a french company (NGBiotech). This study is therefore a feasibility study of a rapid test for oestradiol dosage during monitoring of ovarian stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful tests | Number of tests yieling a result (whatever the value) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Rate of true positive test results (comparison with oestradiol level in blood sample, as gold standard) | Through study completion, an average of 1 month |
| Specificity | Rate of true negative test results (comparison with oestradiol level in blood sample, as gold standard) |
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Inclusion criteria:
Exclusion Criteria:
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Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celia RAVEL, MD, PhD | Contact | +3332 99 26 59 16 | cela.ravel@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Celia RAVEL, MD, PhD | Rennes University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Through study completion, an average of 1 month |