InfertilityPhase 2NCT02309671
A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
A Phase 2 study testing FE 999049 and follitropin beta in people with Infertility, run by Ferring Pharmaceuticals at 1 site in Japan.
Trial summary
This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- FE 999049 and follitropin beta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to Sep 2016
- Phase
- Phase 2
- 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 20 to 39 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 and/or ICSI treatment
- Women aged 20-39 years
- Women with body mass index (BMI) of 17.5-32.0 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
1 site in 1 country.
Japan1 site
Investigational site (there may be other sites in this country)
Tokyo
About this study
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme
This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.
- Conditions
- Infertility
- Being tested
- FE 999049, follitropin beta
- 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
follitropin betaDrug
Also called FOLLISTIM
| Study group | Role | What they receive |
|---|---|---|
| FE 999049 6 µg | Experimental | Not described Receives: Drug: FE 999049 |
| FE 999049 9 µg | Experimental | Not described Receives: Drug: FE 999049 |
| FE 999049 12 µg | Experimental | Not described Receives: Drug: FE 999049 |
| FOLLISTIM 150 IU | Active comparator | follitropin beta Receives: Drug: follitropin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Measured: End of stimulation (max 16 days after investigational medicinal product (IMP) start)
Secondary outcomes (8)
Number of follicles during stimulation
Measured: Up to 16 days
Size of follicles during stimulation
Measured: Up to 16 days
Endocrine profile measured by circulating levels of hormones
Measured: Up to 16 days
Total IMP dose administered measured from first until last dose (end of stimulation)
Measured: Up to 16 days
Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing
Measured: 5 days (from oocyte retrieval to embryo transfer)
Successful pregnancy rate
Measured: 5-6 weeks after transfer
Frequency of adverse events
Measured: From signing informed consent form until end of trial visit = 8-9 weeks
Intensity of adverse events
Measured: From signing informed consent form until end of trial visit = 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 159 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
- NCT02309671
- Sponsor's protocol ID
- 000124
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2014
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Publications
Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril. 2021 Jun;115(6):1478-1486. doi: 10.1016/j.fertnstert.2020.10.059. Epub 2020 Dec 4.
PubMed 33272623
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme
- ClinicalTrials.gov ID
- NCT02309671
- Acronym / sponsor ID
- 000124
- Conditions
- Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Dec 2014 (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.
This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FE 999049 6 µg | Experimental | Drug: FE 999049 |
| FE 999049 9 µg | Experimental | Drug: FE 999049 |
| FE 999049 12 µg | Experimental | Drug: FE 999049 |
| FOLLISTIM 150 IU | Active comparator | Drug: follitropin betafollitropin beta |
Who may qualify
- Ages
- 20 to 39 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 and/or ICSI treatment
- Women aged 20-39 years
- Women with body mass index (BMI) of 17.5-32.0 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 | FE 999049 12 µg, FE 999049 6 µg, FE 999049 9 µg |
| follitropin betaAlso: FOLLISTIM | Drug | FOLLISTIM 150 IU |
Primary outcome
Number of oocytes retrieved
Time frame: End of stimulation (max 16 days after investigational medicinal product (IMP) start)
8 secondary outcomes
Number of follicles during stimulation
Time frame: Up to 16 days
Size of follicles during stimulation
Time frame: Up to 16 days
Endocrine profile measured by circulating levels of hormones
Time frame: Up to 16 days
Total IMP dose administered measured from first until last dose (end of stimulation)
Time frame: Up to 16 days
Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing
Time frame: 5 days (from oocyte retrieval to embryo transfer)
Successful pregnancy rate
Time frame: 5-6 weeks after transfer
Frequency of adverse events
Time frame: From signing informed consent form until end of trial visit = 8-9 weeks
Intensity of adverse events
Time frame: From signing informed consent form until end of trial visit = 8-9 weeks
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 14 Dec 2020.
- Results publication: PubMed 33272623Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril. 2021 Jun;115(6):1478-1486. doi: 10.1016/j.fertnstert.2020.10.059. Epub 2020 Dec 4.
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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?
A Phase 2 study testing FE 999049 and follitropin beta in people with Infertility, run by Ferring Pharmaceuticals at 1 site in Japan.
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 14 Dec 2020. 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 Japan. 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?
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?
Number of oocytes retrieved (time frame: End of stimulation (max 16 days after investigational medicinal product (IMP) start)). 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 NCT02309671, which also lists 1 linked publication.
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 14 Dec 2020.