Clinical trial NCT01183143: 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Ovulation Induction
In-Vitro Fertilization
Keywords: Infertility
Ovulation induction
Gonal-F
Follitropin alpha
Controlled ovarian stimulation
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-08-17
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator
timeFrame: Up to 1 year
measure: Evaluation of the Information Given to the Subjects on the Pen's Utilization
timeFrame: Up to 1 year
measure: Duration of Ovarian Stimulation With GONAL-f®
timeFrame: Up to 1 year
measure: Mean Number of Embryos Transferred
timeFrame: End of Stimulation period (up to a maximum 26 days)
measure: Total and Average Daily Dose of GONAL-f®
timeFrame: Up to 26 days
measure: Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI)
timeFrame: Up to 20 Weeks of Gestation
measure: Number of Subjects With Live Birth
timeFrame: End of Gestation period, assessed up to a maximum of 1 year
measure: Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator
timeFrame: Up to 1 year
measure: Number of Subjects With at Least 1 Adverse Event
timeFrame: Up to 1 year
measure: Number of Subjects Taking at Least 1 Concomitant Treatment
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please Contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: