Improved Medically Assisted Procreation Monitoring

• Conditions: Infertility
• Interventions: Diagnostic Test: Dosage of oestradiol

• Registration Number: NCT03274765
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2017-08-31
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-04
• Last Update Submitted: 2017-09-04
• Study First Posted: 2017-09-07
• Last Update Posted: 2017-09-07
• Study Start: 2017-11-15
• Primary Completion: 2018-06-15
• Study Completion: 2018-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Adult under safeguard of justice, guardianship or curatorship
• Persons deprived of liberty.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with ovarian stimulation	Dosage of oestradiol	Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol

Primary Outcome Measures

Name	Time	Method
Rate of successful tests	1 hour	Number of tests yieling a result (whatever the value)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France