Phase 3
N=215
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
Infertility · Ovulation Induction · In-Vitro Fertilization
Bottom Line
View on ClinicalTrials.gov: NCT01183143 ↗Enrolled (actual)
215
Serious AEs
2.8%
Results posted
Apr 2018
Primary outcome: Primary: Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP) — 159 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GONAL-f® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP) |
159 | — |
| SECONDARY Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator |
101; 93; 1 | — |
| SECONDARY Evaluation of the Information Given to the Subjects on the Pen's Utilization |
89; 95; 5; 1; 95; 89 | — |
| SECONDARY Duration of Ovarian Stimulation With GONAL-f® |
10 | — |
| SECONDARY Mean Number of Embryos Transferred |
1.8 | — |
| SECONDARY Total and Average Daily Dose of GONAL-f® |
1527; 149.5 | — |
| SECONDARY Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI) |
16.5; 16.5; 16.5 | — |
| SECONDARY Number of Subjects With Live Birth |
41 | — |
| SECONDARY Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator |
32; 3; 34; 8; 41 | — |
| SECONDARY Number of Subjects With at Least 1 Adverse Event |
36 | — |
| SECONDARY Number of Subjects Taking at Least 1 Concomitant Treatment |
28 | — |
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 fertilization (IVF).
Eligibility 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/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
Data sourced from ClinicalTrials.gov (NCT01183143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.