Infertility
Conditions
Keywords
ovarian stimulation, blood test, Medically Assisted Procreation
Brief summary
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
Detailed description
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.
Interventions
DIAGNOSTIC_TESTDosage of oestradiol
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.
Sponsors
Rennes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women over 18 years old * Patient followed for monitoring of ovarian stimulation; * Having received information on the protocol and given consent to participate
Exclusion criteria
* Adult under safeguard of justice, guardianship or curatorship * Persons deprived of liberty.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful tests | 1 hour | Number of tests yieling a result (whatever the value) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Through study completion, an average of 1 month | Rate of true positive test results (comparison with oestradiol level in blood sample, as gold standard) |
| Specificity | Through study completion, an average of 1 month | Rate of true negative test results (comparison with oestradiol level in blood sample, as gold standard) |
Countries
France
Contacts
Primary ContactCelia RAVEL, MD, PhD
Outcome results
None listed