Infertility, FemaleMEDAMNCT04876300
MEDAM (Menopur Retrospective Data prograM)
An observational study of Infertility, Female, run by Ferring Pharmaceuticals at 10 sites in France.
Trial summary
French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility, Female
- How many people
- 11,488 participants
- Where
- 10 sitesFrance
- Study dates
- 4 Nov 2021to 30 Nov 2021
- 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: Adult women, fitting the inclusion/exclusion criteria, who were prescribed Menotropin during 2009 to 2016 for COS in a treatment of infertility will be included in this study.
Who may be able to join
- Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016
Who cannot join
- Ovulation inductions
- Intra-uterine inseminations
- Fertility preservations
- Oocyte donations
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Ferring investigational site
Bondy, 93140
Ferring investigational site
Clamart, 92140
Ferring investigational site
Créteil, 94010
Ferring investigational site
Le Chesnay, 78150
Ferring investigational site
Lens, 62190
Ferring investigational site
Lyon, 69002
Ferring investigational site
Marseille, 13008
Ferring investigational site
Nice, 06100
Ferring investigational site
Rennes, 35000
Ferring investigational site
Rennes, 35033
About this study
Official title: Predicting the Cumulative Live Birth Rate Further Ovarian Stimulation by Highly Purified Human Menotropin HP-hMG. A Multicentre, Retrospective Study
French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.
- Conditions
- Infertility, Female
- Being tested
- No intervention
- Keywords
- Menotropin, HP-hMG
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study will take place.
| Study group | Role | What they receive |
|---|---|---|
| Menotropin Cohort | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate (cLBR)
Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.
Measured: At delivery
Secondary outcomes (6)
Initial dose of Menotropin treatment per IVF cycle (IU)
Measured: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
Total dose of Menotropin treatment per IVF cycle (IU)
Measured: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
Total days of Menotropin treatment (per IVF cycle)
Duration of treatment (in days) with Menotropin of patients will be reported.
Measured: Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016
Dose adjustment of Menotropin in IU
Measured: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist)
Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist.
Measured: At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016
Total days of LH surge suppression protocol
Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist.
Measured: From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start4 Nov 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Retrospective
- Enrolment
- 11,488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876300
- Sponsor's protocol ID
- 000376
- Acronym
- MEDAM
- Status last verified
- Nov 2021
- First submitted
- 3 May 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Cumulative Live Birth Rate Further Ovarian Stimulation by Highly Purified Human Menotropin HP-hMG. A Multicentre, Retrospective Study
- ClinicalTrials.gov ID
- NCT04876300
- Acronym / sponsor ID
- MEDAM / 000376
- Conditions
- Infertility, Female
- Keywords
- Menotropin, HP-hMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,488 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 6 May 2021 (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.
French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Menotropin Cohort | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult women, fitting the inclusion/exclusion criteria, who were prescribed Menotropin during 2009 to 2016 for COS in a treatment of infertility will be included in this study.
Key inclusion criteria (1 listed)
- Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016
Key exclusion criteria (4 listed)
- Ovulation inductions
- Intra-uterine inseminations
- Fertility preservations
- Oocyte donations
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 |
|---|---|---|
| No interventionAll directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study will take place. | Other | Menotropin Cohort |
Primary outcome
Cumulative live birth rate (cLBR)
Time frame: At delivery
Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.
6 secondary outcomes
Initial dose of Menotropin treatment per IVF cycle (IU)
Time frame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
Total dose of Menotropin treatment per IVF cycle (IU)
Time frame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
Total days of Menotropin treatment (per IVF cycle)
Time frame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016
Dose adjustment of Menotropin in IU
Time frame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist)
Time frame: At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016
Total days of LH surge suppression protocol
Time frame: From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016
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 25 Jan 2022.
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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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Ferring Pharmaceuticals at 10 sites 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 1 inclusion and 4 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Cumulative live birth rate (cLBR) (time frame: At delivery). 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 25 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.