Improved Medically Assisted Procreation Monitoring

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Improved Medically Assisted Procreation (MAP) Monitoring

Conditions
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Infertility

Intervention / Treatment
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* Diagnostic Test: Dosage of oestradiol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with ovarian stimulation<br>Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol | Diagnostic Test: Dosage of oestradiol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful tests | Number of tests yieling a result (whatever the value) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | 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) | Through study completion, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian stimulation, blood test, Medically Assisted Procreation