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

• Status: Completed
• Trial end date: 2006-03-02
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Follicle Stimulating Hormone

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