To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01081639
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : July 31, 2014
Merck Serono GmbH, Germany
Information provided by:
Merck KGaA

Brief Summary:
This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with follitropin beta (Puregon) liquid pen.

Condition or disease Intervention/treatment Phase
Infertility Ovulation Induction Drug: Follitropin alfa liquid formulation Drug: Follitropin beta liquid formulation Phase 3

Detailed Description:

Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as in-vitro fertilisation (IVF) and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF/intracytoplasmic sperm injection (ICSI) currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotrophin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH in terms of requiring fewer ampules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.

Recently, a new formulation of follitropin alfa has been developed due to a general trend in the field of therapeutic recombinant proteins to move from presentations based on biological activity to presentations based on physico-chemical characteristics. Until now follitropin alfa has been produced as a powder for injection (either as monodose or multidose preparations) in glass ampoules or in glass vials and administered using plastic or glass syringe. Serono developed a multidose solution for injection in a prefilled disposable injection pen. This study involved comparing the administration of follitropin alfa liquid formulation applied by pen with that of follitropin beta liquid formulation also applied by pen.

OBJECTIVES The objectives of this study were to evaluate the convenience, safety and efficacy of Follitropin alfa (Gonal-f) liquid pen compared with Follitropin beta (Puregon) liquid pen.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study on the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Formulation Applied by a Pen Versus Follitropin Beta Liquid Formulation Applied by Pen
Study Start Date : November 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Arm Intervention/treatment
Experimental: Gonal-f Drug: Follitropin alfa liquid formulation
Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Other Name: Gonal-f
Active Comparator: Puregon Drug: Follitropin beta liquid formulation
Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Other Name: Puregon

Primary Outcome Measures :
  1. Convenience and Safety [ Time Frame: 1 year ]

    Convenience parameters included nurse/subjects preference; time to train subject; operative tolerance and wastage of product which were assessed during the post-treatment period.

    Safety parameters included local reactions (pain, bruising, redness, itching, swelling)and adverse drug events which were assessed during the pre-treatment, treatment and post-treatment period.

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 1 year ]
    Collection of routine data from the RecDate registry such as: stimulation duration; FSH starting dose; FSH dosage on last treatment day; total amount of gonadotrophin needed; number of follicles on the day of the last ultra-scan; number of oocytes retrieved; number of fertilized oocytes; number of embryos transferred; wastage of product; number of cartridges of Gonal-f (300 IU, 450 IU, and 900 IU) and Puregon (300 IU and 600 IU) opened; clinical pregnancy by Ultra-scan (if already available at time point of final report writing).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pre-menopausal woman, between her 18th and 39th birthday, receiving recombinant FSH as stimulation for IVF and/or ICSI
  • Subjects who were able to communicate well with the investigator and to comply with the requirements of the entire study
  • Subjects who had given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice

Exclusion Criteria:

  • Subjects who had known allergic reaction against one of the ingredients
  • Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries (PCO)
  • Subjects with gynaecological bleeding of unknown origin
  • Subjects who had ovarian, uterine, or mammary cancer
  • Subjects with tumors of the hypothalamus or the pituitary gland

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01081639

Sponsors and Collaborators
Merck KGaA
Merck Serono GmbH, Germany
Principal Investigator: Christoph Keck, PD, Dr. med. Universitätsfrauenklinik Freiburg

Publications of Results:
Responsible Party: PD Dr. habil. Christoph Keck, Universitätsfrauenklinik, Hugstetter Straße 55, 79106 Freiburg Identifier: NCT01081639     History of Changes
Other Study ID Numbers: IMP 24554
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: November 2010

Keywords provided by Merck KGaA:
Follitropin alfa
Follitropin beta
Fertilization, in vitro
Intracytoplasmic sperm injection
Assisted reproductive techniques
Polycystic ovary syndrome

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs