Back to resultsConvenience 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 (Prestyje)
Primary Purpose
Infertility, Ovulation Induction, In-Vitro Fertilization
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
GONAL-f®
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, Ovulation induction, Gonal-F, Follitropin alpha, Controlled ovarian stimulation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Please Contact the Merck KGaA Communication Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GONAL-f®
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Duration of Ovarian Stimulation With GONAL-f®
Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment.
Mean Number of Embryos Transferred
Total and Average Daily Dose of GONAL-f®
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.
Number of Subjects With Live Birth
Number of subjects whose stimulation with the IMP resulted in the birth of a baby were reported.
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.
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.
Number of Subjects Taking at Least 1 Concomitant Treatment
Full Information
NCT ID
NCT01183143
First Posted
August 16, 2010
Last Updated
April 5, 2018
Sponsor
Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01183143
Brief Title
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
Acronym
Prestyje
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 11, 2004 (Actual)
Primary Completion Date
March 2, 2006 (Actual)
Study Completion Date
March 2, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Ovulation Induction, In-Vitro Fertilization
Keywords
Infertility, Ovulation induction, Gonal-F, Follitropin alpha, Controlled ovarian stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GONAL-f®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GONAL-f®
Other Intervention Name(s)
Follitropin alpha
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)
Description
Number of subjects who self-administered the IMP were presented in this outcome measure.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator
Description
Investigator evaluated the use of GONAL-f® prefilled pen in subjects as very satisfactory, satisfactory and average satisfaction.
Time Frame
Up to 1 year
Title
Evaluation of the Information Given to the Subjects on the Pen's Utilization
Description
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.
Time Frame
Up to 1 year
Title
Duration of Ovarian Stimulation With GONAL-f®
Description
Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment.
Time Frame
Up to 1 year
Title
Mean Number of Embryos Transferred
Time Frame
End of Stimulation period (up to a maximum 26 days)
Title
Total and Average Daily Dose of GONAL-f®
Time Frame
Up to 26 days
Title
Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI)
Description
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.
Time Frame
Up to 20 Weeks of Gestation
Title
Number of Subjects With Live Birth
Description
Number of subjects whose stimulation with the IMP resulted in the birth of a baby were reported.
Time Frame
End of Gestation period, assessed up to a maximum of 1 year
Title
Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator
Description
Local tolerance at the GONAL-f ® injection site was assessed for the presence of pain, swelling/welt, redness, itch and haematoma.
Time Frame
Up to 1 year
Title
Number of Subjects With at Least 1 Adverse Event
Description
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.
Time Frame
Up to 1 year
Title
Number of Subjects Taking at Least 1 Concomitant Treatment
Time Frame
Up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Please Contact the Merck KGaA Communication Center
City
Darmstadt
ZIP/Postal Code
64293
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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
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