InfertilityAMENCT02935335
A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®
An observational study of Infertility, run by Ferring Pharmaceuticals at 1 site in France.
Trial summary
AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Menotrophin
- How many people
- 297 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to 19 Jun 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 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Specialized fertility centers.
Who may be able to join
- Women aged between [18-42] years.
- Both ovaries present.
- Regular menstrual cycles presumed to be ovulatory.
- Primary or secondary infertility of any origin for more than 12 months.
- Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion.
- Candidates eligible to a first IVF/ICSI cycle and for whom Menopur® HP-hMG 600 IU/mL has been prescribed.
- Having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written Informed Consent Form.
Who cannot join
- Major uterine or ovarian morphological abnormalities or past ovarian surgery.
- Endometriosis stage III/IV.
- Polycystic ovarian syndrome.
- Major endocrine or metabolic abnormalities without treatment.
- Patient included in an interventional study assessing treatment for infertility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.
AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.
- Conditions
- Infertility
- Being tested
- Menotrophin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenotrophinDrug
Also called Menopur® HP-hMG
| Study group | Role | What they receive |
|---|---|---|
| Menopur® HP-hMG | Treatment according to routine clinical practice. Receives: Drug: Menotrophin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels
Measured: At baseline (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion31 Jan 2018
- Study completion19 Jun 2018
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
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935335
- Sponsor's protocol ID
- 000237
- Acronym
- AME
- Status last verified
- Mar 2019
- First submitted
- 14 Oct 2016
- Last updated
- 5 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.
- ClinicalTrials.gov ID
- NCT02935335
- Acronym / sponsor ID
- AME / 000237
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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.
AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menopur® HP-hMG | – | Drug: MenotrophinTreatment according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Specialized fertility centers.
Key inclusion criteria (7 listed)
- Women aged between [18-42] years.
- Both ovaries present.
- Regular menstrual cycles presumed to be ovulatory.
- Primary or secondary infertility of any origin for more than 12 months.
- Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion.
Key exclusion criteria (5 listed)
- Major uterine or ovarian morphological abnormalities or past ovarian surgery.
- Endometriosis stage III/IV.
- Polycystic ovarian syndrome.
- Major endocrine or metabolic abnormalities without treatment.
- Patient included in an interventional study assessing treatment for infertility.
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 |
|---|---|---|
| MenotrophinAlso: Menopur® HP-hMG | Drug | Menopur® HP-hMG |
Primary outcome
Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels
Time frame: At baseline (inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
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 Ferring Pharmaceuticals 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 5 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels (time frame: At baseline (inclusion)). 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 5 Mar 2019.