Improved Medically Assisted Procreation Monitoring

Rennes University Hospital30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Infertility

Interventions

Dosage of oestradiolDIAGNOSTIC_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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rennes University Hospital

Rennes, France

Outcomes

Primary Outcomes

Rate of successful tests

Number of tests yieling a result (whatever the value)

Time frame: 1 hour

Secondary Outcomes

Sensitivity

Rate of true positive test results (comparison with oestradiol level in blood sample, as gold standard)

Time frame: 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)

Time frame: Through study completion, an average of 1 month

Central Contacts

Celia RAVEL, MD, PhD

CONTACT

+3332 99 26 59 16 cela.ravel@chu-rennes.fr

Data from ClinicalTrials.gov

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