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
Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility; Ovulation Induction; In-Vitro Fertilization
Intervention: Follitropin alpha (Gonal-F) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s): Rachel LEVY TOLEDANO, Study Director, Affiliation: Merck Sante S.A.S. France
Summary
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).
Clinical Details
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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The number of patients who self-administered the Investigational Medicinal Product.
Secondary outcome: Evaluation of the information given to the patients on the pen's utilisation.Efficacy of the stimulation protocols using GONAL-f® prefilled pen. Local tolerance at the GONAL-f ® injection site. Adverse events Concomitant treatments
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
Minimum age: 18 Years.
Maximum age: 43 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: May 2004
Last updated: March 17, 2014
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