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)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01183143
First received: August 16, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 fertilisation (IVF).


Condition Intervention Phase
Infertility
Ovulation Induction
In-Vitro Fertilization
Drug: Follitropin alpha (Gonal-F)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • The number of patients who self-administered the Investigational Medicinal Product. [ Time Frame: until day HCG 12-14 ] [ Designated as safety issue: No ]

    Evaluation of the acceptability of GONAL-f ® liquid formulation administered by pen with the aid of a patient questionnaire in usual clinical practice. The principle criterion of evaluation is to determine the proportion of patients who practiced auto-injection.

    From screening visit to pregnancy or non pregnancy confirmation



Secondary Outcome Measures:
  • Evaluation of the information given to the patients on the pen's utilisation. [ Time Frame: until day HCG 12-14 ] [ Designated as safety issue: No ]
    Evaluation of the information given to the patients on the GONAL-f® prefilled pen's utilisation and the global evaluation of the IMP by the investigator.

  • Efficacy of the stimulation protocols using GONAL-f® prefilled pen. [ Time Frame: until day HCG 12-14 ] [ Designated as safety issue: No ]
    Efficacy of the stimulation protocols using GONAL-f® prefilled pen: Pregnancy rate for the OI/IUI and number of live birth; Number of retrieval, fertilised oocytes, number of transferred embryo, pregnancy rate per puncture or transfer; Total and daily dose of GONAL-f® delivered; Stimulation duration

  • Local tolerance at the GONAL-f ® injection site. [ Time Frame: until day HCG 12-14 ] [ Designated as safety issue: Yes ]
    Local tolerance at the GONAL-f ® injection site (pain, swelling/welt, redness, itch, haematoma)

  • Adverse events [ Time Frame: until day HCG 12-14 ] [ Designated as safety issue: Yes ]
    Adverse events (patient, pregnancy, foetus/baby)

  • Concomitant treatments [ Time Frame: until day HCG 12-14 ] [ Designated as safety issue: Yes ]

Enrollment: 215
Study Start Date: May 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Follitropin alpha (Gonal-F)
    In a common setting, for OI the starting daily dose of Gonal-F will be 75-150 IU generally not exceeding beyond 225 IU. The starting dose of Gonal-F in IVF/ICSI will be 150-225 IU/day not exceeding beyond 450 IU/day.
    Other Name: Gonal-F
Detailed Description:

Ovarian stimulation in IVF or intracytosolic sperm injection (ICSI) currently includes suppression of endogenous luteinising hormone (LH) suppression by administration of either a gonadotropin releasing hormone (GnRH) agonist or a GnRH antagonist, followed by stimulation of multiple follicular development by exogenous follicle stimulating hormone (FSH) administration. When an adequate follicular development is achieved, a single human chorionic gonadotropin (hCG) dose is administered to mimic the endogenic LH surge and induce final oocyte maturation. In common setting, the purpose of the ovarian stimulation is to obtain a monofollicular development, for ovulation induction and the first line treatment is represented by clomiphene. Follicle stimulating hormone gonadotropins are indicated in case of clomiphene failure.

OBJECTIVES

  • To assess, in common setting, convenience, safety, and efficacy of protocols using Gonal-F fbm liquid formulation applied by pen for OI and IVF/ICSI procedures.

The study was designed to primarily collect safety data related to the usage of the Gonal-F fbm liquid formulation, in addition to the post treatment assessment of convenience in subjects treated with Gonal-F fbm. In OI or intrauterine insemination (IUI), the objective of ovarian stimulation was monofollicular development and the initiation of treatment took place in the the first 7 days of the cycle. The initial daily dose of Gonal-F was 75-150 International Unit (IU) and then was increased preferably by 37.5 IU or 50 IU or 75 IU (maximal dose should not exceeding 225 IU) at 7 or preferably 14 day intervals if necessary, to obtain an adequate but not excessive response. In IVF or ICSI the objective was superovulation, with multiple follicules development and the initiation of treatment at J2-J3 of the cycle was at the starting dose of 150-225 IU. The study was continued till the confirmation of pregnancy or non pregnancy.

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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/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 processus
  • Subjects with premature menopause
  • Subjects with gynaecological 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 allergia, atopic asthma disease,
  • Subjects with known allergic reaction against one of the FSH and ingredients,
  • On going pregnant, or breast feeding subjects
  • Subjects who have participated in a trial during the last 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183143

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Rachel LEVY TOLEDANO Merck Sante S.A.S. France
  More Information

No publications provided

Responsible Party: Rachel LEVY-TOLEDANO, Merck Sante S.A.S. France, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01183143     History of Changes
Other Study ID Numbers: IMP 25040
Study First Received: August 16, 2010
Last Updated: March 17, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Merck KGaA:
Infertility
Ovulation induction
Gonal-F
Follitropin alpha
Controlled ovarian stimulation.

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

ClinicalTrials.gov processed this record on October 30, 2014