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)
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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 |
- 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
- 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: | May 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
-
Drug: Follitropin alpha (Gonal-F)
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 |
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 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: | September 3, 2010 |
| 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, Male Genital Diseases, Female Follicle Stimulating Hormone |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013