InfertilityPhase 3NCT01312766
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
A Phase 3 study testing Menotropins in people with Infertility, run by IBSA Institut Biochimique SA at 6 sites in 5 countries.
Trial summary
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Menotropins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Feb 2011to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing ovarian stimulation for IVF with the following characteristics:
- Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
- >18 and <40 years old
- BMI between 18 and 30 kg/m2
- less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)
- basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l)
- Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination
- Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness < 7mm or serum E2 level <50 pg/ml (~185 pmol/l).
Who cannot join
- age <18 and >40 years
- primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration <500pg/ml (~1800 pmol/l))
- PCOS
- one or both ovaries inaccessible for oocyte retrieval
- ovarian cysts >10 mm
- hydrosalpinx that have not been surgically removed or ligated;
Show all 16Show fewer
- stage 3 or 4 endometriosis
- oocyte donation
- implantation of previously frozen embryos
- patients affected by pathologies associated with any contraindication of being pregnant
- hypersensitivity to the study medication
- abnormal bleeding of undetermined origin
- uncontrolled thyroid or adrenal dysfunction
- neoplasias
- severe impairment of renal and/or hepatic function
- use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Denmark2 sites
Fertility clinic at Hvidovre Hospital
Hvidovre, Copenhagen, 2650
Odense Universitetshospital
Odense, Odensee C, 5000
Hungary1 site
First Dept. Obstetric and Gynaecology, Semmelweiss University
Budapest, 1088
Switzerland1 site
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
United Kingdom1 site
Midland Fertility Services
Aldridge, West Midlands, WS9 8LT
About this study
Official title: Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
- Conditions
- Infertility
- Being tested
- Menotropins
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenotropinsDrug
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
MenotropinsDrug
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
| Study group | Role | What they receive |
|---|---|---|
| hMG-IBSA | Experimental | New hMG preparation. Receives: Drug: Menotropins |
| Menopur | Active comparator | Not described Receives: Drug: Menotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Oocytes Retrieved
Measured: up to 24 days after treatment start
Secondary outcomes (12)
Mean hMG Dose (Total);
Measured: up to 22 days after treatment start
Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)
Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.
Measured: up to 28 days after treatment start
Positive b-hCG Test
Measured: up to 5 weeks after treatment start
Controlled Ovarian Stimulation Duration (Days)
Measured: up to 23 days after treatment start
17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;
Measured: up to 23 days after treatment start
Implantation Rate
defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;
Measured: 10-11 weeks after embryo transfer
Clinical Pregnancy Rate,
defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;
Measured: 10 - 11 weeks after embryo transfer
Number of Mature (Grade III Metaphase II) Oocytes Retrieved.
Measured: at the end of the stimulation.
Ratio Mature/Total Number of Oocytes Retrieved.
Percentage of retrieved oocytes considered to be mature.
Measured: at the end of the stimulation.
Total Number of Inseminated Oocytes (IVF and ICSI)
number of oocytes that were inseminated via IVF or injected via ICSI technique.
Measured: on the day of oocyte retrieval
Number of Cleaved Embryos
Measured: two days after insemination
Live Birth Rate
Measured: 9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominique De Ziegler, MD, Prof, Principal investigator, Hopital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312766
- Sponsor's protocol ID
- 10EU/hMG02
- Other IDs
- 2010-021021-13
- Status last verified
- Jun 2016
- First submitted
- 7 Mar 2011
- Last updated
- 22 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)
- ClinicalTrials.gov ID
- NCT01312766
- Acronym / sponsor ID
- 10EU/hMG02
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hMG-IBSA | Experimental | Drug: MenotropinsNew hMG preparation. |
| Menopur | Active comparator | Drug: Menotropins |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women undergoing ovarian stimulation for IVF with the following characteristics:
Key exclusion criteria (16 listed)
- age <18 and >40 years
- primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration <500pg/ml (~1800 pmol/l))
- PCOS
- one or both ovaries inaccessible for oocyte retrieval
- ovarian cysts >10 mm
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 |
|---|---|---|
| MenotropinsDaily administration, SC, starting dose 150 IU or 225 IU depending on patient age. | Drug | hMG-IBSA |
| MenotropinsDaily administration, SC, starting dose 150 IU or 225 IU depending on patient age. | Drug | Menopur |
Primary outcome
Total Number of Oocytes Retrieved
Time frame: up to 24 days after treatment start
12 secondary outcomes
Mean hMG Dose (Total);
Time frame: up to 22 days after treatment start
Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)
Time frame: up to 28 days after treatment start
Positive b-hCG Test
Time frame: up to 5 weeks after treatment start
Controlled Ovarian Stimulation Duration (Days)
Time frame: up to 23 days after treatment start
17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;
Time frame: up to 23 days after treatment start
Implantation Rate
Time frame: 10-11 weeks after embryo transfer
Clinical Pregnancy Rate,
Time frame: 10 - 11 weeks after embryo transfer
Number of Mature (Grade III Metaphase II) Oocytes Retrieved.
Time frame: at the end of the stimulation.
Ratio Mature/Total Number of Oocytes Retrieved.
Time frame: at the end of the stimulation.
Total Number of Inseminated Oocytes (IVF and ICSI)
Time frame: on the day of oocyte retrieval
Number of Cleaved Embryos
Time frame: two days after insemination
Live Birth Rate
Time frame: 9 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Dominique De Ziegler, MD, Prof principal investigator
Hopital Cochin
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Menotropins in people with Infertility, run by IBSA Institut Biochimique SA at 6 sites in 5 countries.
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 8 inclusion and 16 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 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, France, Hungary, Switzerland, United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Oocytes Retrieved (time frame: up to 24 days after treatment start). 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 22 Jul 2016.