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 - Full Text View

Purpose

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.

Condition	Intervention
Infertility	Other: Quality of Life Questionnaire (FertiQoL)

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Post Marketing Assessment of GONAL-f Solution for Injection in a Prefilled Pen for Follicular Stimulation in IVF-ET Cycles: An Observational Study

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

Proportion of subjects who preferred the Gonal-f (FbM) Pen to vials [ Time Frame: Post-treatment with Gonal-f (2 weeks after embryo transfer) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of effectiveness of Gonal-f [ Time Frame: One stimulation treatment cycle until 7 weeks of intrauterine pregnancy or mensuration ] [ Designated as safety issue: No ]
Total dose of r-hFSH used during the stimulation period, number of days of stimulation treatment, cancellation rates (not administring hCG due to poor response to stimulation), total number of retrieved oocytes (34-36 hours after hCG administration), mean number of embryos transferred, embryo implantation rate, number of miscarriages, registration of body mass index (BMI), registration of smoking habit (previous or present)
Local tolerance of Gonal-f (FbM) solution for injection in a prefilled pen [ Time Frame: Screening period to post-treatment with Gonal-f (until 7 weeks of intrauterine pregnancy) ] [ Designated as safety issue: Yes ]
Local tolerance of Gonal-f (FbM) solution for injection in a prefilled pen (pain, bruising, redness, itching, swelling as documented by the subject) and adverse events encountered during the study

Biospecimen Retention: Samples Without DNA

Plasma

Enrollment:	61
Study Start Date:	February 2011
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 will be administered the first internationally validated Quality of Life questionnaire (FertiQoL) to assess the quality of life of infertile subjects. Other Name: 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) Subjects will be administered the first internationally validated Quality of Life questionnaire (FertiQoL) to assess the quality of life of infertile subjects. Other Name: FertiQoL

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 43 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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

Criteria

Inclusion Criteria:

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
Subjects who have early follicular phase (day 2-4) serum level of basal FSH lower and equal to 12 IU/L measured in the centre's local laboratory (i.e. within 2 months prior to inclusion).
If subject is supposed to gone through ovarian induction (OI), criteria for inclusion in the study is to receive the treatment with the Gonal f (FbM) Prefilled Pen for at least 5-6 days

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125462

Locations

Serbia
Dept. for Human Reproduction, Clinical Centre Vojvodina
Novi Sad, Branimira Ćosića 37, Serbia, 21 000
University hospital for Gynaecology and Obstetrics "Narodni front", Dept. for ART
Belgrade, Kraljice Marije 62, Serbia, 11 000
Clinical Centre Serbia, Visegradska
Belgrade, Serbia, 11 000

Sponsors and Collaborators

Merck KGaA

Merck d.o.o., Serbia

Investigators

Study Director:

Jasmina Cvetkovic, PhD

Merck d.o.o., Serbia

More Information

No publications provided

Responsible Party:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT01125462 History of Changes
Other Study ID Numbers:	EMR 700623-517
Study First Received:	May 17, 2010
Last Updated:	July 31, 2012
Health Authority:	Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by Merck KGaA:

Ovulation Induction
Infertility
Gonal-f
FertiQoL
Quality of Life

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013

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 (POINT)