Infertility Clinical Trial
— POINTOfficial title:
Post Marketing Assessment of GONAL-f Solution for Injection in a Prefilled Pen for Follicular Stimulation in IVF-ET Cycles: An Observational Study
Verified date | July 2012 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Study type | Observational |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility |
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techniques such as IVF - Subjects who have given written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice for her future medical care - Female subjects between 18-43 years of age who have undergone at least one treatment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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Serbia | Clinical Centre Serbia, Visegradska | Belgrade | |
Serbia | University hospital for Gynaecology and Obstetrics "Narodni front", Dept. for ART | Belgrade | Kraljice Marije 62 |
Serbia | Dept. for Human Reproduction, Clinical Centre Vojvodina | Novi Sad | Branimira Cosica 37 |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA | Merck d.o.o., Serbia |
Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects who preferred the Gonal-f (FbM) Pen to vials | Post-treatment with Gonal-f (2 weeks after embryo transfer) | No | |
Secondary | Assessment of effectiveness of Gonal-f | 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) | One stimulation treatment cycle until 7 weeks of intrauterine pregnancy or mensuration | No |
Secondary | Local tolerance of Gonal-f (FbM) solution for injection in a prefilled pen | 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 | Screening period to post-treatment with Gonal-f (until 7 weeks of intrauterine pregnancy) | Yes |
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