Improved Medically Assisted Procreation Monitoring

NCT ID: NCT03274765

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-15

Study Completion Date

2018-12-15

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.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with ovarian stimulation

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

Dosage of oestradiol

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celia RAVEL, MD, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Locations

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Rennes University Hospital

Rennes, , France

Site Status

Countries

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France

Central Contacts

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Celia RAVEL, MD, PhD

Role: CONTACT

+3332 99 26 59 16

Facility Contacts

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Celia RAVEL, MD, PhD

Role: primary

Other Identifiers

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35RC15_3019

Identifier Type: -

Identifier Source: org_study_id

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