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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
215
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.
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Darmstadt, Germany
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.
Time frame: Up to 1 year
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.
Time frame: 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.
Time frame: 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.
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)
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
Number of Subjects With Live Birth
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
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.
Time frame: 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.
Time frame: Up to 1 year
Number of Subjects Taking at Least 1 Concomitant Treatment
Time frame: Up to 1 year
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