InfertilityPhase 2NCT01426386
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
A Phase 2 study testing FE 999049 and Gonal - F in people with Infertility, run by Ferring Pharmaceuticals at 8 sites in 4 countries.
Trial summary
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- FE 999049 and Gonal - F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2011to Mar 2013
- Phase
- Phase 2
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
- Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
- Women aged 18-37 years
- Women with body mass index (BMI) of 18.5-32.0 kg/m2
Who cannot join
- Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
- Women with history of recurrent miscarriage
- Women with contraindications to controlled ovarian stimulation with gonadotropins
- Women with three or more controlled ovarian stimulation cycles
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Spain4 sites
IU Dexeus
Barcelona
IVI Madrid
Madrid
IVI Sevilla
Seville
IVI Valencia
Valencia
About this study
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
- Conditions
- Infertility
- Being tested
- FE 999049, Gonal - F
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE 999049Drug
Gonal - FDrug
| Study group | Role | What they receive |
|---|---|---|
| 5.2 µg | Experimental | Not described Receives: Drug: FE 999049 |
| 6.9 µg | Experimental | Not described Receives: Drug: FE 999049 |
| 8.6 µg | Experimental | Not described Receives: Drug: FE 999049 |
| 10.3 µg | Experimental | Not described Receives: Drug: FE 999049 |
| 12.1 µg | Experimental | Not described Receives: Drug: FE 999049 |
| 11 µg FbM (150 IU) | Active comparator | Not described Receives: Drug: Gonal - F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
Measured: Day of oocyte retrieval (up to Day 18 after start of stimulation)
Secondary outcomes (7)
Number and Size of Follicles During Stimulation
Follicular volume at end of stimulation
Measured: End of stimulation (up to 16 stimulation days)
Endocrine Profile
Estradiol at end of stimulation
Measured: End of stimulation (up to 16 stimulation days)
Total IMP Dose
Measured: End of stimulation (up to 16 stimulation days)
Number of Fertilised Oocytes
An oocyte with 2 pronuclei was regarded as correctly fertilised
Measured: Day 1 after insemination
Number and Quality of Blastocysts on Day 5
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher
Measured: Day 5 after oocyte retrieval
Clinical Pregnancy With Fetal Heart Beat Rate
Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat
Measured: 5-6 weeks after transfer
Frequency and Intensity of Adverse Events
Measured: From signing informed consent form until end of trial visit (up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionMar 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 265 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
- NCT01426386
- Sponsor's protocol ID
- 000009
- Other IDs
- 2011-000633-36
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2011
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.
PubMed 32819842Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, Barri P, de Sutter P, Klein BM, Fauser BC. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40.e5. doi: 10.1016/j.fertnstert.2014.08.013. Epub 2014 Sep 23.
PubMed 25256937
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
- ClinicalTrials.gov ID
- NCT01426386
- Acronym / sponsor ID
- 000009
- Conditions
- Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 3 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 5.2 µg | Experimental | Drug: FE 999049 |
| 6.9 µg | Experimental | Drug: FE 999049 |
| 8.6 µg | Experimental | Drug: FE 999049 |
| 10.3 µg | Experimental | Drug: FE 999049 |
| 12.1 µg | Experimental | Drug: FE 999049 |
| 11 µg FbM (150 IU) | Active comparator | Drug: Gonal - F |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
- Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
- Women aged 18-37 years
- Women with body mass index (BMI) of 18.5-32.0 kg/m2
Key exclusion criteria (4 listed)
- Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
- Women with history of recurrent miscarriage
- Women with contraindications to controlled ovarian stimulation with gonadotropins
- Women with three or more controlled ovarian stimulation cycles
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 |
|---|---|---|
| FE 999049 | Drug | 10.3 µg, 12.1 µg, 5.2 µg, 6.9 µg, 8.6 µg |
| Gonal - F | Drug | 11 µg FbM (150 IU) |
Primary outcome
Number of Oocytes Retrieved
Time frame: Day of oocyte retrieval (up to Day 18 after start of stimulation)
7 secondary outcomes
Number and Size of Follicles During Stimulation
Time frame: End of stimulation (up to 16 stimulation days)
Endocrine Profile
Time frame: End of stimulation (up to 16 stimulation days)
Total IMP Dose
Time frame: End of stimulation (up to 16 stimulation days)
Number of Fertilised Oocytes
Time frame: Day 1 after insemination
Number and Quality of Blastocysts on Day 5
Time frame: Day 5 after oocyte retrieval
Clinical Pregnancy With Fetal Heart Beat Rate
Time frame: 5-6 weeks after transfer
Frequency and Intensity of Adverse Events
Time frame: From signing informed consent form until end of trial visit (up to 5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32819842Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.
- Derived from this study: PubMed 25256937Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, Barri P, de Sutter P, Klein BM, Fauser BC. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40.e5. doi: 10.1016/j.fertnstert.2014.08.013. Epub 2014 Sep 23.
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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
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FE 999049 and Gonal - F in people with Infertility, run by Ferring Pharmaceuticals at 8 sites in 4 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 4 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Belgium, Czechia, Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Aug 2018). 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?
Number of Oocytes Retrieved (time frame: Day of oocyte retrieval (up to Day 18 after start of stimulation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426386, which also lists 2 linked publications.
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 17 Nov 2020.