Status:
COMPLETED
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
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Infertility
Ovulation Induction
Eligibility:
FEMALE
18-43 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2006
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT01183143
Start Date
May 11 2004
End Date
March 2 2006
Last Update
April 6 2018
Active Locations (1)
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1
Please Contact the Merck KGaA Communication Center
Darmstadt, Germany, 64293