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 (Prestyje)
|ClinicalTrials.gov Identifier: NCT01183143|
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infertility Ovulation Induction In-Vitro Fertilization||Drug: GONAL-f®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 11, 2004|
|Actual Primary Completion Date :||March 2, 2006|
|Actual Study Completion Date :||March 2, 2006|
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.
Other Name: Follitropin alpha
- 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.
- Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator [ Time Frame: Up to 1 year ]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 [ Time Frame: Up to 1 year ]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® [ Time Frame: Up to 1 year ]Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment.
- 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 ]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 [ Time Frame: End of Gestation period, assessed up to a maximum of 1 year ]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 [ Time Frame: Up to 1 year ]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 [ Time Frame: Up to 1 year ]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 [ Time Frame: Up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183143
|Please Contact the Merck KGaA Communication Center|
|Darmstadt, Germany, 64293|
|Study Director:||Medical Responsible||Merck KGaA|