InfertilityPhase 3NCT01121666
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
A Phase 3 study testing Follitropin alfa in people with Infertility, run by Finox AG at 16 sites in 6 countries.
Trial summary
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Follitropin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 16 sitesin 6 countries
- Study dates
- Jun 2010to Mar 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 38 years with regular menstrual cycles of 25-35 days
- First or second cycle in the present series of ART
- BMI ≥ 18 ≤ 30 kg/m2
- Basal FSH < 10 IU/L (cycle day 2-5)
- E2 levels < 50pg/mL (< 0.18 nmol/L) at the day of FSH administration
- Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries)
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- Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility
- Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation)
- Willingness to participate in the study and to comply with the study protocol
- Informed consent
Who cannot join
- Presence of pregnancy
- History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy
- Presence of clinically significant systemic disease
- Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
- Presence of uncontrolled endocrine disorder
- Previous history or presence of severe ovarian hyperstimulation syndrome
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- Presence of polycystic ovaries (PCO)
- Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx
- Neoplasia, including tumors of the hypothalamus and pituitary gland
- Abnormal bleeding of undetermined origin
- History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
- Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA)
- Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening
- Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin)
- History of drug, nicotine or alcohol abuse within the last 12 months (> 10 cigarettes/day)
- Administration of other investigational products within the last month
- Clinically abnormal findings at Visit 1
- Planned PGS/PGD/PBB or assisted hatching
- Concomitant participation in an other study protocol
- History of extrauterine pregnancy in the previous 3 months
- Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®)
- Presence or history of thrombophlebitis or thromboembolic disorders
- Presence or history of cerebral haemorrhage
- Presence or history of porphyria
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Austria5 sites
Kinderwunsch Institut Schenk GmbH
Graz
Landes-Frauenklinik und Kinderklinik Linz
Linz
AKH Vienna
Vienna, 1090
IVF Zentrum Döbling
Vienna, 11920
Privatspital Goldenes Kreuz
Vienna
Denmark3 sites
Fertility Clinic
Copenhagen, 2100
Copenhagen Fertility Center
Copenhagen, 2400
Dansk Fertilitetsklinik
Frederiksberg, 2000
United Kingdom3 sites
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Kings College Hospital
London
St Barthlomew's Hospital
London
Germany2 sites
Universitätsklinikum Bonn
Bonn, 53105
Universitäts-Frauenklinik
Heidelberg
Spain2 sites
Institut Universitari Dexeus
Barcelona, 08028
IVI Madrid
Madrid, 28023
About this study
Official title: A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
- Conditions
- Infertility
- Being tested
- Follitropin alfa
- Keywords
- Assisted reproductive treatment, Superovulation, Follitropin alfa, r-hFSH, AFOLIA
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin alfaDrug
150IU per day subcutaneously for a maximum of 16 days
| Study group | Role | What they receive |
|---|---|---|
| Gonal-f® (Follitropin alfa) | Active comparator | Not described Receives: Drug: Follitropin alfa |
| AFOLIA-150 (Follitropin alfa) | Experimental | Not described Receives: Drug: Follitropin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved (Per Protocol Population)
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.
The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Measured: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
Number of Oocytes Retrieved (Intention-to-treat Population)
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.
The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Measured: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
Secondary outcomes (21)
Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation
The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.
Measured: Day 8 of stimulation
E2 Concentration at Day 8 and at Day of hCG Administration
The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.
Measured: Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)
Total Dose of r-hFSH Administered
Total dose of r-hFSH required was assessed.
Measured: Day of hCG administration (after maximum 16 days of r-hFSH treatment)
Quality of Oocytes Retrieved
Number of patients with ovum pick-up
Measured: 34-36 hours after hCG administration
Fertilisation Rate of Oocytes
Fertilisation rate was assessed
Measured: 1 day after ovum pick-up
Embryo Quality: Mean Number of Blastomeres
Main embryo quality parameter "mean number of blastomeres"
Measured: Day 2 of OPU/fertilisation
Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts
Measured: Day 1, 2, 3 and 5 of OPU/fertilisation
Number of Days of r-hFSH Stimulation
Mean duration of stimulation was assessed.
Measured: At the day of hCG administration, up to 16 days
Number of Patients With Cycle Cancellation
Number of patients with cycle cancellation was assessed.
Measured: Until child birth/miscarriage, up to the end of the study
Number of Patients With Good Response
Good response was defined as "patients with an oocyte retrieval of four or more oocytes"
Measured: Until child birth/miscarriage, up to the end of the study
Implantation Rate
Defined as fetal sac per embryo transferred.
Measured: Five to six weeks after oocyte retrieval
Clinical Pregnancy Rate
Presence of at least one intrauterine gestational sac.
Measured: Five to six weeks after oocyte retrieval
Ongoing Pregnancy
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
Measured: Ten weeks after embryo transfer
Live Birth Rate
Patients with liveborn children
Measured: After childbirth with questionnaire
Embryo Quality: Absence of Multinucleation
Main embryo quality parameter "absence of multinucleation" observed.
Measured: Day 3
Quality of Oocytes Retrieved
Number of patients with transferred blastocysts
Measured: At day 4 and 5
Quality of Oocytes Retrieved
Number of embryos per blastocysts transferred
Measured: Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval
Clinical Pregnancy Rate (Second Treatment Cycle)
Presence of at least one intrauterine gestational sac.
Measured: Five to six weeks after oocyte retrieval
Ongoing Pregnancy (Second Treatment Cycle)
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
Measured: 10 weeks after embryo transfer
Quality of Oocytes Retrieved
The maturity of the cumulus oophorus was assessed.
Measured: After oocyte retrieval, 34 to 36 hours after hCG administration
Quality of Oocytes Retrieved
The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).
Measured: After oocyte retrieval, 34 to 36 hours after hCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- 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.
- 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
- Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finox AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Imthurn, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121666
- Sponsor's protocol ID
- FIN3001
- Other IDs
- 2010-019287-37
- Status last verified
- Mar 2016
- First submitted
- 10 May 2010
- Last updated
- 15 Apr 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 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment
- ClinicalTrials.gov ID
- NCT01121666
- Acronym / sponsor ID
- FIN3001
- Conditions
- Infertility
- Keywords
- Assisted reproductive treatment, Superovulation, Follitropin alfa, r-hFSH, AFOLIA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Finox AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Posted 15 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gonal-f® (Follitropin alfa) | Active comparator | Drug: Follitropin alfa |
| AFOLIA-150 (Follitropin alfa) | Experimental | Drug: Follitropin alfa |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 20 and 38 years with regular menstrual cycles of 25-35 days
- First or second cycle in the present series of ART
- BMI ≥ 18 ≤ 30 kg/m2
- Basal FSH < 10 IU/L (cycle day 2-5)
- E2 levels < 50pg/mL (< 0.18 nmol/L) at the day of FSH administration
Key exclusion criteria (24 listed)
- Presence of pregnancy
- History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy
- Presence of clinically significant systemic disease
- Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
- Presence of uncontrolled endocrine disorder
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 |
|---|---|---|
| Follitropin alfa150IU per day subcutaneously for a maximum of 16 days | Drug | AFOLIA-150 (Follitropin alfa), Gonal-f® (Follitropin alfa) |
Primary outcome
Number of Oocytes Retrieved (Per Protocol Population)
Time frame: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Number of Oocytes Retrieved (Intention-to-treat Population)
Time frame: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
21 secondary outcomes
Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation
Time frame: Day 8 of stimulation
E2 Concentration at Day 8 and at Day of hCG Administration
Time frame: Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)
Total Dose of r-hFSH Administered
Time frame: Day of hCG administration (after maximum 16 days of r-hFSH treatment)
Quality of Oocytes Retrieved
Time frame: 34-36 hours after hCG administration
Fertilisation Rate of Oocytes
Time frame: 1 day after ovum pick-up
Embryo Quality: Mean Number of Blastomeres
Time frame: Day 2 of OPU/fertilisation
Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts
Time frame: Day 1, 2, 3 and 5 of OPU/fertilisation
Number of Days of r-hFSH Stimulation
Time frame: At the day of hCG administration, up to 16 days
Number of Patients With Cycle Cancellation
Time frame: Until child birth/miscarriage, up to the end of the study
Number of Patients With Good Response
Time frame: Until child birth/miscarriage, up to the end of the study
Implantation Rate
Time frame: Five to six weeks after oocyte retrieval
Clinical Pregnancy Rate
Time frame: Five to six weeks after oocyte retrieval
Ongoing Pregnancy
Time frame: Ten weeks after embryo transfer
Live Birth Rate
Time frame: After childbirth with questionnaire
Embryo Quality: Absence of Multinucleation
Time frame: Day 3
Quality of Oocytes Retrieved
Time frame: At day 4 and 5
Quality of Oocytes Retrieved
Time frame: Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval
Clinical Pregnancy Rate (Second Treatment Cycle)
Time frame: Five to six weeks after oocyte retrieval
Ongoing Pregnancy (Second Treatment Cycle)
Time frame: 10 weeks after embryo transfer
Quality of Oocytes Retrieved
Time frame: After oocyte retrieval, 34 to 36 hours after hCG administration
Quality of Oocytes Retrieved
Time frame: After oocyte retrieval, 34 to 36 hours after hCG administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bruno Imthurn principal investigator
University of Zurich
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Follitropin alfa in people with Infertility, run by Finox AG at 16 sites in 6 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 10 inclusion and 24 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 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Austria, Denmark, United Kingdom, Germany, Spain and 1 more country. 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 Apr 2016). 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 (Per Protocol Population) (time frame: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment). The study lists 2 primary outcomes in all. 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 15 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.