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

NCT01183143 | Completed Phase 3 Results

• 1 other identifier: IMP 25040
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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 formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

Conditions

Infertility; Ovulation Induction; In-Vitro Fertilization

Keywords

Infertility; Ovulation induction; Gonal-F; Follitropin alpha; Controlled ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)

  Number of subjects who self-administered the IMP were presented in this outcome measure.

  Up to 1 year

Secondary Outcomes (10)

• Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator

  Up to 1 year

• Evaluation of the Information Given to the Subjects on the Pen's Utilization

  Up to 1 year

• Duration of Ovarian Stimulation With GONAL-f®

  Up to 1 year

• Mean Number of Embryos Transferred

  End of Stimulation period (up to a maximum 26 days)

• Total and Average Daily Dose of GONAL-f®

  Up to 26 days

Study Arms (1)

GONAL-f®

EXPERIMENTAL

Drug: GONAL-f®

Interventions

GONAL-f® DRUG

GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.

Also known as: Follitropin alpha

GONAL-f®

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Please Contact the Merck KGaA Communication Center

Darmstadt, 64293, Germany

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Glycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 17, 2010
• Study Start: May 11, 2004
• Primary Completion: March 2, 2006
• Study Completion: March 2, 2006
• Last Updated: April 6, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-04

Locations

DE (1)