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)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: In-Vitro Fertilization; Infertility; Ovulation Induction

Treatments: Drug: GONAL-f®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01183143

IMP 25040

Details and patient eligibility

About

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).

Enrollment: 215 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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215 participants in 1 patient group

GONAL-f®

Experimental group

Treatment:

Drug: GONAL-f®