Improved Medically Assisted Procreation Monitoring (NGAMP)

September 4, 2017 updated by: Rennes University Hospital

Improved Medically Assisted Procreation (MAP) Monitoring

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

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with ovarian stimulation
Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion, an average of 1 month
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
Time Frame: Through study completion, an average of 1 month
Rate of true negative test results (comparison with oestradiol level in blood sample, as gold standard)
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Study Director: Celia RAVEL, MD, PhD, Chu Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2017

Primary Completion (Anticipated)

June 15, 2018

Study Completion (Anticipated)

December 15, 2018

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

September 4, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC15_3019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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