InfertilityPhase 3PrestyjeNCT01183143
Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization
A Phase 3 study testing GONAL-f® in people with Infertility and Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility, Ovulation Induction, In-Vitro Fertilization
- What is being tested?
- GONAL-f®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteGermany
- Study dates
- 11 May 2004to 2 Mar 2006
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects aged between 18 and 43 years
- Ambulatory subjects
- Subjects who are willing to get pregnant and are infertile, that justifies ovarian stimulation treatment for mono-/pauci-follicular development (OI or IUI) or multiple follicular development for IVF/Intracytoplasmic Sperm Injection (ICSI) procedures
- Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
- Subjects who have given written informed consent, prior to treatment
Who cannot join
- Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries
- Subjects with extra-uterine pregnancy during the last 3 months
- Subjects with several endometriosis (Grade III \& IV)
- Subjects with history of severe ovarian hyperstimulation syndrome
- Subjects with history of thromboembolic event
- Subjects with malformative uterine pathology that could disturb either implantation or pregnancy processes
Show all 14Show fewer
- Subjects with premature menopause
- Subjects with gynecological bleeding of unknown origin
- Subjects with ovarian, uterine, or mammary cancer
- Subjects with tumors of the hypothalamus or the pituitary glands
- Subjects with history of serious allergy or atopic asthma disease
- Subjects with known allergic reaction against one of the Follicle Stimulating Hormone (FSH) and ingredients,
- Ongoing pregnant, or breast feeding subjects
- Subjects who have participated in a trial during the last 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Please Contact the Merck KGaA Communication Center
Darmstadt, 64293
About this study
Official title: A Multicentre, Open-label, Non-comparative Phase IIIb Study to Evaluate the Acceptability of GONAL-f® Prefilled Liquid Formulation Administered by Pen in an Outpatient Setting for Ovarian Stimulation
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).
- Conditions
- Infertility, Ovulation Induction, In-Vitro Fertilization
- Being tested
- GONAL-f®
- Keywords
- Infertility, Ovulation induction, Gonal-F, Follitropin alpha, Controlled ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GONAL-f®Drug
Also called Follitropin alpha
GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.
| Study group | Role | What they receive |
|---|---|---|
| GONAL-f® | Experimental | 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 Subjects Who Self-administered the Investigational Medicinal Product (IMP)
Number of subjects who self-administered the IMP were presented in this outcome measure.
Measured: Up to 1 year
Secondary outcomes (10)
Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator
Investigator evaluated the use of GONAL-f® prefilled pen in subjects as very satisfactory, satisfactory and average satisfaction.
Measured: Up to 1 year
Evaluation of the Information Given to the Subjects on the Pen's Utilization
Subjects were provided with the information on Pen's utilization via training session and in the form of information brochure. Subjects assessed both the methods using the following responses: satisfactory, satisfactory, unsatisfactory and very unsatisfactory.
Measured: Up to 1 year
Duration of Ovarian Stimulation With GONAL-f®
Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment.
Measured: Up to 1 year
Mean Number of Embryos Transferred
Measured: End of Stimulation period (up to a maximum 26 days)
Total and Average Daily Dose of GONAL-f®
Measured: Up to 26 days
Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI)
Pregnancy rate was defined as the percentage of subjects with diagnosis of pregnancy, who underwent OI/IUI. Clinical pregnancy: Evidence of pregnancy by clinical or ultrasound parameters at 12 weeks after fertilization. Biochemical pregnancy: Evidence of conception based only on biochemical data in the serum or urine before ultrasound evidence of a gestational sac. Ongoing pregnancy was defined when the pregnancy had completed 20 weeks of gestation.
Measured: Up to 20 Weeks of Gestation
Number of Subjects With Live Birth
Number of subjects whose stimulation with the IMP resulted in the birth of a baby were reported.
Measured: End of Gestation period, assessed up to a maximum of 1 year
Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator
Local tolerance at the GONAL-f ® injection site was assessed for the presence of pain, swelling/welt, redness, itch and haematoma.
Measured: Up to 1 year
Number of Subjects With at Least 1 Adverse Event
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerged or worsened relative to baseline (i.e. present at the initial study visit) during a clinical study with an investigational product, regardless of causal relationship and even if no investigational product has been administered.
Measured: Up to 1 year
Number of Subjects Taking at Least 1 Concomitant Treatment
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study start11 May 2004
- Primary completion2 Mar 2006
- Study completion2 Mar 2006
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183143
- Sponsor's protocol ID
- IMP 25040
- Acronym
- Prestyje
- Status last verified
- Apr 2018
- First submitted
- 16 Aug 2010
- Last updated
- 6 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Non-comparative Phase IIIb Study to Evaluate the Acceptability of GONAL-f® Prefilled Liquid Formulation Administered by Pen in an Outpatient Setting for Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT01183143
- Acronym / sponsor ID
- Prestyje / IMP 25040
- Conditions
- Infertility, Ovulation Induction, In-Vitro Fertilization
- Keywords
- Infertility, Ovulation induction, Gonal-F, Follitropin alpha, Controlled ovarian stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 11 May 2004 (actual)
- Primary completion
- 2 Mar 2006 (actual)
- Study completion
- 2 Mar 2006 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Posted 6 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GONAL-f® | Experimental | Drug: GONAL-f® |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects aged between 18 and 43 years
- Ambulatory subjects
- Subjects who are willing to get pregnant and are infertile, that justifies ovarian stimulation treatment for mono-/pauci-follicular development (OI or IUI) or multiple follicular development for IVF/Intracytoplasmic Sperm Injection (ICSI) procedures
- Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
- Subjects who have given written informed consent, prior to treatment
Key exclusion criteria (14 listed)
- Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries
- Subjects with extra-uterine pregnancy during the last 3 months
- Subjects with several endometriosis (Grade III \& IV)
- Subjects with history of severe ovarian hyperstimulation syndrome
- Subjects with history of thromboembolic event
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 |
|---|---|---|
| GONAL-f®Also: Follitropin alphaGONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed. | Drug | GONAL-f® |
Primary outcome
Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)
Time frame: Up to 1 year
Number of subjects who self-administered the IMP were presented in this outcome measure.
10 secondary outcomes
Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator
Time frame: Up to 1 year
Evaluation of the Information Given to the Subjects on the Pen's Utilization
Time frame: Up to 1 year
Duration of Ovarian Stimulation With GONAL-f®
Time frame: Up to 1 year
Mean Number of Embryos Transferred
Time frame: End of Stimulation period (up to a maximum 26 days)
Total and Average Daily Dose of GONAL-f®
Time frame: Up to 26 days
Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI)
Time frame: Up to 20 Weeks of Gestation
Number of Subjects With Live Birth
Time frame: End of Gestation period, assessed up to a maximum of 1 year
Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator
Time frame: Up to 1 year
Number of Subjects With at Least 1 Adverse Event
Time frame: Up to 1 year
Number of Subjects Taking at Least 1 Concomitant Treatment
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- 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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GONAL-f® in people with Infertility and Ovulation Induction, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
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 5 inclusion and 14 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 6 Apr 2018. 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 Germany. 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 6 Apr 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 Subjects Who Self-administered the Investigational Medicinal Product (IMP) (time frame: Up to 1 year). 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 6 Apr 2018.