A Post Marketing Assessment of Gonal f Solution for Injection in a Prefilled Pen for Follicular Stimulation in in Vitro Fertilisation/Embryo Transfer (IVF-ET) Cycles

NCT01125462 | Completed

• 1 other identifier: EMR 700623-517
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

The development of recombinant DNA technology, culminated in the introduction of the first recombinant human follicle stimulating hormone (r hFSH), Gonal-f, which further developed to become Gonal-f Filled-by-Mass (FbM) pen has been used in the fertility treatment since many years. It has been found that subjects using the pen found it less stressful, easier to use and more convenient than a conventional syringe and would recommend the prefilled pen to another woman considering gonadotropin treatment. However, the use of the Gonal-f (FbM) pen between Serbian subjects is on a very low level though the Gonal f vials with the 75 IU of follitropin alfa have been present in Serbian market since 2003. On the contrary from the clinical practice in European countries, Serbian subjects usually receive daily dose of injectable gonadotropins at the IVF clinics or by partner/family member. This open-label, multicentric, observational non-interventional study is designed with the aim to know the reason of Serbian subjects not injecting themselves with Gonal f and the quality of life (QoL) of Serbian women/couples with the infertility problem.

Conditions

Infertility

Keywords

Ovulation Induction; Infertility; Gonal-f; FertiQoL; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who preferred the Gonal-f (FbM) Pen to vials

  Post-treatment with Gonal-f (2 weeks after embryo transfer)

Secondary Outcomes (2)

• Assessment of effectiveness of Gonal-f

  One stimulation treatment cycle until 7 weeks of intrauterine pregnancy or mensuration

• Local tolerance of Gonal-f (FbM) solution for injection in a prefilled pen

  Screening period to post-treatment with Gonal-f (until 7 weeks of intrauterine pregnancy)

Study Arms (2)

Subjects previously treated with Gonal-f

Subjects who had undergone at least one treatment cycle with Gonal-f powder and solvent for solution for injection within the past 12 months (equivalent to 75 IU/ml, 450 IU/0.75ml or 1050 IU/1.75 ml)

Other: Quality of Life Questionnaire (FertiQoL)

Subjects previously treated with urine-derived FSH

Subjects which had undergone at least one treatment cycle with urine-derived FSH therapy with vials within the past 12 months

Other: Quality of Life Questionnaire (FertiQoL)

Interventions

Quality of Life Questionnaire (FertiQoL) OTHER

Subjects will be administered the first internationally validated Quality of Life questionnaire (FertiQoL) to assess the quality of life of infertile subjects.

Also known as: FertiQoL

Subjects previously treated with Gonal-f; Subjects previously treated with urine-derived FSH

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pre-menopausal woman, between 18-43 years old requiring treatment with recombinant FSH for controlled ovarian hyperstimulation for IVF or OI in Serbia

You may qualify if:

• Women undergoing superovulation prior to assisted reproductive techniques such as IVF
• Subjects who have given written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice for her future medical care
• Female subjects between 18-43 years of age who have undergone at least one treatment cycle and as such are not included in the fertility reimbursed program supported by Serbian Ministry of Health
• Subjects willing and able to comply with the protocol for the duration of the study

You may not qualify if:

• Subjects with ovarian, uterine or mammary cancer
• Pregnancy and lactation period
• Subjects with tumours of the hypothalamus and pituitary gland
• Subjects with uterine myoma requiring treatment
• Subjects with ovarian enlargement or cyst of unknown aetiology
• Subjects with a clinically significant systemic disease
• Subjects with abnormal gynaecological bleeding of undetermined origin
• Subjects with known allergy or hypersensitivity to human gonadotropin preparations
• Subjects who have entered previously into this study or simultaneous participation in another study
• Subjects with legal incapacity or limited legal capacity

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck d.o.o., Serbia: collaborator

Study Sites (3)

Dept. for Human Reproduction, Clinical Centre Vojvodina

Novi Sad, Branimira Ćosića 37, 21 000, Serbia

Location

University hospital for Gynaecology and Obstetrics "Narodni front", Dept. for ART

Belgrade, Kraljice Marije 62, 11 000, Serbia

Location

Clinical Centre Serbia, Visegradska

Belgrade, 11 000, Serbia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jasmina Cvetkovic, PhD

  Merck d.o.o., Serbia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 16, 2014

Record last verified: 2012-07

Locations

SE (3)