InfertilityNGAMPNCT03274765
Improved Medically Assisted Procreation Monitoring
An observational study of Infertility, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Dosage of oestradiol
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2017to 15 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring
Who may be able to join
- Women over 18 years old
- Patient followed for monitoring of ovarian stimulation;
- Having received information on the protocol and given consent to participate
Who cannot join
- Adult under safeguard of justice, guardianship or curatorship
- Persons deprived of liberty.
Trial locations and contacts
1 site in 1 country.
France1 site
Rennes University Hospital
Rennes, 35000
Celia RAVEL, MD, PhD, celia.ravel@chu-rennes.fr
About this study
Official title: 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
Read the 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.
- Conditions
- Infertility
- Being tested
- Dosage of oestradiol
- Keywords
- ovarian stimulation, blood test, Medically Assisted Procreation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with ovarian stimulation | Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol Receives: Diagnostic Test: Dosage of oestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful tests
Number of tests yieling a result (whatever the value)
Measured: 1 hour
Secondary outcomes (2)
Sensitivity
Rate of true positive test results (comparison with oestradiol level in blood sample, as gold standard)
Measured: 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)
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start15 Nov 2017 (estimated)
- Primary completion15 Jun 2018 (estimated)
- Study completion15 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celia RAVEL, MD, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274765
- Sponsor's protocol ID
- 35RC15_3019
- Acronym
- NGAMP
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Medically Assisted Procreation (MAP) Monitoring
- ClinicalTrials.gov ID
- NCT03274765
- Acronym / sponsor ID
- NGAMP / 35RC15_3019
- Conditions
- Infertility
- Keywords
- ovarian stimulation, blood test, Medically Assisted Procreation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2017 (estimated)
- Primary completion
- 15 Jun 2018 (estimated)
- Study completion
- 15 Dec 2018 (estimated)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with ovarian stimulation | – | Diagnostic Test: Dosage of oestradiolWomen followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring Dosage of oestradiol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring
Key inclusion criteria (3 listed)
- Women over 18 years old
- Patient followed for monitoring of ovarian stimulation;
- Having received information on the protocol and given consent to participate
Key exclusion criteria (2 listed)
- Adult under safeguard of justice, guardianship or curatorship
- Persons deprived of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dosage of oestradiolThe 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. | Diagnostic test | Women with ovarian stimulation |
Primary outcome
Rate of successful tests
Time frame: 1 hour
Number of tests yieling a result (whatever the value)
2 secondary outcomes
Sensitivity
Time frame: Through study completion, an average of 1 month
Specificity
Time frame: Through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia RAVEL, MD, PhD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia RAVEL, MD, PhD (+3332 99 26 59 16, cela.ravel@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful tests (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.