Improved Medically Assisted Procreation Monitoring

Infertility Clinical Trial

— NGAMP  

Official title:

Improved Medically Assisted Procreation (MAP) Monitoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03274765
• Other study ID #: 35RC15_3019
• Status: Not yet recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: September 4, 2017
• Start date: November 15, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: September 2017
• Source: Rennes University Hospital
• Contact: Celia RAVEL, MD, PhD
• Phone: +3332 99 26 59 16
• Email: cela.ravel[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Diagnostic Test:
• Dosage 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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful tests	Number of tests yieling a result (whatever the value)	1 hour
Secondary	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
Secondary	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