Infertility Clinical Trial
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
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.
Fertility is the ability to conceive or induce conception. A normal fertile couple has about
a 20% chance of achieving pregnancy in any one month of unprotected intercourse. Infertility
is defined as the failure to conceive after 12 months of unprotected intercourse. It is
generally estimated that about 10% to 15% of couples can be classified as having conception
difficulties. About 30% of these are as a result of female factors, 30% as a result of male
factors and a further 30% are due to a combination of both male and female factors. In about
10% of cases, the underlying cause is not found (unexplained fertility).
Follicle-stimulating hormone is one of the key hormones regulating reproductive functions
both in females and males. In females, it stimulates the development of ovarian follicles
which carry the oocytes, while in males it promotes spermatogenesis. Follicle-stimulating
hormone binding to its receptor triggers intracellular mechanisms that regulate
steroidogenesis, cell replication and expression of specific proteins and growth that
modulate gametogenesis. Complete or partial deficiencies in FSH secretion are common causes
of infertility in both women and men. Administration of FSH, either alone or in combination
with luteinizing hormone (LH), has been used successfully to treat these infertility
problems. Nearly 40% of women who are infertile have an ovulatory problem. These disorders
may originate in the pituitary, the hypothalamus, the ovaries, or the anatomy of the
reproductive system.
Over the last 50 years the quality of FSH used in fertility treatment for inducing
follicular development has improved via several distinguishable steps. For many years only
human menopausal gonadotropin (hMG), a mixture of human LH and FSH extracted from the urine
of post-menopausal women, was available for treatment of infertility. However, Merck Serono
has developed the recombinant human FSH (r-hFSH) for clinical use, which has been in the
market for several years. This development has been guided by the quest for control over the
variability in urinary derived drugs. The recombinant system is a well-defined and
controlled manufacturing process, which means that the content of these recombinant
gonadotropins is consistent from batch-to-batch, accurately measured and filled-by-mass
(i.e. in terms of weight in micrograms). This allows precise dosing control in both
ovulation induction (OI) and assisted reproduction techniques (ART). Recombinant human
fertility hormones are considered to have consistency of the source material and of the
active product, the purity and specific activity of the protein, a good efficacy, safety and
tolerability.
OBJECTIVES
Primary objective:
- To evaluate the ease-of-use of Gonal-f (FbM) in a prefilled pen in normal clinical
practice conditions under different protocols of follicular stimulation
Secondary objective:
- To evaluate the local tolerability (incidence of local reaction at the injection site)
to drug administration.
This study is planned to be conducted in 3 IVF/ART clinics in Serbia recruiting
approximately 20 subjects per centre (10 to each group) giving a total of 60 subjects.
Subjects with previous stimulation treatment by the use of some injectable gonadotropins and
not the stimulation with clomiphene citrate will be enrolled in this study. Depending on the
kind of gonadotropin used in the previous stimulation treatment the subject has been treated
with (meaning either Gonal-f ampules or urinary derived drugs), subjects will be stratified
into two groups. The first group will include subjects who have 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). The second group will
include subjects which had undergone at least one treatment cycle with urine-derived FSH
therapy with vials within the past 12 months. Subjects in both groups included in the study
will be treated according to the Summary of Product Characteristics (SmPC) and according to
clinical practice at each site. These subjects will also answer on questions from the first
internationally validated QoL questionnaire called FertiQoL. The FertiQoL is the instrument
that surveys infertile subjects to assess their QoL. Each and every subject will undergo one
stimulation treatment cycle and each subject should be followed for approximately 2 weeks or
until chemically proven pregnancy. After treatment, subject satisfaction with the Gonal f
(FbM) prefilled pen will be measured using a post-treatment questionnaire in which
participants will be asked to compare their treatment experiences and choose a preferred
injection method.
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Observational Model: Case-Only, Time Perspective: Prospective
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