InfertilityNCT01115725
A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Greece.
Trial summary
This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization (IVF) or intracytoplasmic sperm injection… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Gonal-f® (follitropin alfa)
- Type of treatment
- Injection or infusion
- How many people
- 76 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2005to Jul 2008
- Phase
- Observational
- 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Primary care clinic
Who may be able to join
- Pre-menopausal female subjects, between their 18th and 39th birthday
- Subjects with body mass index between 18-32 kilogram per square meter (kg/m^2)
- Subjects with FSH (on second day of menstrual cycle) less than 10 milli international unit per milliliter (mIU/ml)
- Subjects who required treatment with recombinant FSH for controlled ovarian hyperstimulation for IVF and/or ICSI
- 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- Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice
Who cannot join
- Subjects who are not pregnant or lactating
- Subjects with known allergic reaction against one of the ingredients
- Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries (PCO)
- Subjects with gynecological bleeding of unknown origin
- Subjects who have ovarian, uterine, or mammary cancer
- Subjects with hyperprolactinemia
- Subjects with tumors of the hypothalamus or the pituitary gland
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study to Evaluate the Ease of Use, Local Tolerance Safety and Effectiveness of Gonal-f® (Filled-by-Mass in a Prefilled Pen)
This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with recombinant follicle stimulating hormone (r-FSH).
Clarification for change of study type:
The study was erroneously registered as an interventional trial on ClinicalTrials.gov between 2010 and 2012. It was shown recently that the study protocol and conduct of the study did not include any clinical interventions beyond those which are Standard Clinical Practice and the approved label for Gonal-f®. Furthermore, all other relevant study essential documentations (e.g. Informed Consent, CRF, etc.) are in line with an observational study design. As per EU regulations (Article 2(c) of Directive 2001/20/EC), this study is a 'non-interventional trial'.
Read the detailed description
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF or ICSI currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotropin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-human chorionic gonadotropin) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH (urinary-derived FSH) in terms of requiring fewer ampoules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.
Recently, a new formulation of follitropin alfa has been developed as the next step in innovation in Serono capitalized on the fact that Serono recognized that follitropin alfa manufacturing was highly controlled and with a controlled specific activity that allowed filling the product by mass guaranteeing the dose being delivered. Until now follitropin alfa has been produced as a lyophilisate for injection (either as single dose or multidose applications) in glass ampoules or in glass vials and administered using syringes. Today, Gonal-f® fill-by-mass is available as a new liquid formulation that can be administered with the pen device which is prefilled and hence the subject does not have to assemble the device making it simpler to use.
OBJECTIVES
Primary objective:
To evaluate the ease-of-use of Gonal-f® (filled by mass in a prefilled pen) in subjects undergoing IVF/ICSI.
Secondary objectives:
To evaluate the local tolerance, safety and effectiveness of Gonal-f® prefilled pens.
- Conditions
- Infertility
- Being tested
- Gonal-f® (follitropin alfa)
- Keywords
- Follitropin alfa, Fertilization in vitro, Intracytoplasmic sperm injection, Reproductive techniques, assisted
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal-f® (follitropin alfa)Drug
Also called Recombinant human follicle stimulating hormone (r-hFSH)
Gonal-f® (follitropin alfa) will be given once daily subcutaneously at a starting dose of 150-375 international unit per day (IU/day) by self-administered injection via a pen device for first 5 days. After Day 5, Gonal-f® dose will be adjusted according to the investigator's discretion until ovarian response observed.
| Study group | Role | What they receive |
|---|---|---|
| Gonal-f® prefilled pen | Not described Receives: Drug: Gonal-f® (follitropin alfa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Convenience assessment
Subjects' to complete ease questionnaire survey for use of Gonal-f prefilled pens.
Measured: Post-treatment assessment (35-42 days post embryo transfer)
Secondary outcomes (2)
Efficacy assessments
Secondary efficacy assessments include evaluation of the duration of stimulation; total amount of gonadotropins needed; number of follicles on the day of the last ultra-sound scan; estradiol (E2) on the day of the last ultra-sound scan; number of oocytes retrieved; number of oocytes fertilised; number of embryos transferred; clinical pregnancy by ultra-sound scan
Measured: Pre-study (within 3 months prior to study start) to days 35-42 post-hCG
Safety and tolerance assessments
Safety will be measured by the incidence and severity of adverse events (AEs) including local reactions; and incidence of ovarian hyperstimulation syndrome (OHSS)
Measured: First stimulation day (S1) to days 15-20 post-hCG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startNov 2005
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Merck A.E. Hellas, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115725
- Sponsor's protocol ID
- IMP25404
- Status last verified
- Dec 2012
- First submitted
- 30 Apr 2010
- Last updated
- 17 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study to Evaluate the Ease of Use, Local Tolerance Safety and Effectiveness of Gonal-f® (Filled-by-Mass in a Prefilled Pen)
- ClinicalTrials.gov ID
- NCT01115725
- Acronym / sponsor ID
- IMP25404
- Conditions
- Infertility
- Keywords
- Follitropin alfa, Fertilization in vitro, Intracytoplasmic sperm injection, Reproductive techniques, assisted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 May 2010 (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 is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with recombinant follicle stimulating hormone (r-FSH).
Clarification for change of study type:
The study was erroneously registered as an interventional trial on ClinicalTrials.gov between 2010 and 2012. It was shown recently that the study protocol and conduct of the study did not include any clinical interventions beyond those which are Standard Clinical Practice and the approved label for Gonal-f®. Furthermore, all other relevant study essential documentations (e.g. Informed Consent, CRF, etc.) are in line with an observational study design. As per EU regulations (Article 2(c) of Directive 2001/20/EC), this study is a 'non-interventional trial'.
Detailed description
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF or ICSI currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotropin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-human chorionic gonadotropin) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH (urinary-derived FSH) in terms of requiring fewer ampoules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.
Recently, a new formulation of follitropin alfa has been developed as the next step in innovation in Serono capitalized on the fact that Serono recognized that follitropin alfa manufacturing was highly controlled and with a controlled specific activity that allowed filling the product by mass guaranteeing the dose being delivered. Until now follitropin alfa has been produced as a lyophilisate for injection (either as single dose or multidose applications) in glass ampoules or in glass vials and administered using syringes. Today, Gonal-f® fill-by-mass is available as a new liquid formulation that can be administered with the pen device which is prefilled and hence the subject does not have to assemble the device making it simpler to use.
OBJECTIVES
Primary objective:
To evaluate the ease-of-use of Gonal-f® (filled by mass in a prefilled pen) in subjects undergoing IVF/ICSI.
Secondary objectives:
To evaluate the local tolerance, safety and effectiveness of Gonal-f® prefilled pens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gonal-f® prefilled pen | – | Drug: Gonal-f® (follitropin alfa) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (6 listed)
- Pre-menopausal female subjects, between their 18th and 39th birthday
- Subjects with body mass index between 18-32 kilogram per square meter (kg/m^2)
- Subjects with FSH (on second day of menstrual cycle) less than 10 milli international unit per milliliter (mIU/ml)
- Subjects who required treatment with recombinant FSH for controlled ovarian hyperstimulation for IVF and/or ICSI
- Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
Key exclusion criteria (7 listed)
- Subjects who are not pregnant or lactating
- Subjects with known allergic reaction against one of the ingredients
- Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries (PCO)
- Subjects with gynecological bleeding of unknown origin
- Subjects who have ovarian, uterine, or mammary cancer
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® (follitropin alfa)Also: Recombinant human follicle stimulating hormone (r-hFSH)Gonal-f® (follitropin alfa) will be given once daily subcutaneously at a starting dose of 150-375 international unit per day (IU/day) by self-administered injection via a pen device for first 5 days. After Day 5, Gonal-f® dose will be adjusted according to the investigator's discretion until ovarian response observed. | Drug | Gonal-f® prefilled pen |
Primary outcome
Convenience assessment
Time frame: Post-treatment assessment (35-42 days post embryo transfer)
Subjects' to complete ease questionnaire survey for use of Gonal-f prefilled pens.
2 secondary outcomes
Efficacy assessments
Time frame: Pre-study (within 3 months prior to study start) to days 35-42 post-hCG
Safety and tolerance assessments
Time frame: First stimulation day (S1) to days 15-20 post-hCG
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 17 Jul 2014.
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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.
Study Director study director
Merck A.E. Hellas, an affiliate of 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?
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Greece.
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 6 inclusion and 7 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 Jul 2014. 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 Greece. 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.
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?
Convenience assessment (time frame: Post-treatment assessment (35-42 days post embryo transfer)). 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 17 Jul 2014.