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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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2014-07-16

No results posted yet for this study

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

Interventions

OTHER

Quality of Life Questionnaire (FertiQoL)

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

Sponsors & Collaborators

  • Merck d.o.o., Serbia

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Jasmina Cvetkovic, PhD · Merck d.o.o., Serbia

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Serbia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125462 on ClinicalTrials.gov