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)

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

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 Overview

• Status: Completed
• Conditions: Infertility; Ovulation Induction; In-Vitro Fertilization
• Intervention / Treatment: Drug: GONAL-f®

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Darmstadt, Germany, 64293
    • Please contact the Merck KGaA Communication Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GONAL-f®

Drug: GONAL-f®; 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 Names: Follitropin alpha

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 1 year
Mean Number of Embryos Transferred		End of Stimulation period (up to a maximum 26 days)
Total and Average Daily Dose of GONAL-f®		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.	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.	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.	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.	Up to 1 year
Number of Subjects Taking at Least 1 Concomitant Treatment		Up to 1 year

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2004
• Primary Completion (Actual): March 2, 2006
• Study Completion (Actual): March 2, 2006

Study Registration Dates

• First Submitted: August 16, 2010
• First Submitted That Met QC Criteria: August 16, 2010
• First Posted (Estimate): August 17, 2010

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Infertility; Ovulation induction; Controlled ovarian stimulation; Follitropin alpha; Gonal-F
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone
• Other Study ID Numbers: IMP 25040