Track topics on Twitter Track topics that are important to you
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.
- 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
- 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.
Observational Model: Case-Only, Time Perspective: Prospective
Quality of Life Questionnaire (FertiQoL)
Dept. for Human Reproduction, Clinical Centre Vojvodina
Branimira Ćosića 37
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:13:39-0400
The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questi...
The purpose of the present study is to advance in the knowledge of quality of life in patients with ILD by translating a ILD quality of life questionnaire. There are no specific tools val...
The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life. The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-...
The purpose of this study is to assess quality-of-life of men with prostate cancer. "Quality-of-life" means how you feel about your life as a result of your disease and its treatment. We h...
EORTC-QLQ-30 questionnaire filled in by participants 6 times
Infertility and its treatment can significantly impact an individual's physical and psychological health; however, this has not been well-studied in the Indian population. This study aimed to assess t...
To investigate the influence of individual characteristics (age, gender, educational level, coping strategies), perceived couple's Dyadic Adjustment, type of diagnosis and duration of infertility on s...
To determine the applicability of the generic instrument Pediatric Quality of Life Inventory (PedsQL 4.0) to assess health-related quality of life of asthmatic children compared to the specific instru...
Actinic keratosis (AK) is a sun-induced skin lesion that may progress to invasive squamous cell carcinoma of the skin. Recently, the Actinic Keratosis Quality of Life questionnaire (AKQoL) was designe...
Lymphedema may affect patients' health-related quality of life (HRQoL) and thus a disease-specific questionnaire is needed. The Lymphedema Quality of life Inventory (LyQLI) has been tested for reliabi...
A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
A quality-of-life scale developed in the United States in 1972 as a measure of health status or dysfunction generated by a disease. It is a behaviorally based questionnaire for patients and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like. It measures the patient's perceived health status and is sensitive enough to detect changes or differences in health status occurring over time or between groups. (From Medical Care, vol.xix, no.8, August 1981, p.787-805)
Self report questionnaire which yields 16 scores on personality traits, such as reserved vs. outgoing, humble vs. assertive, etc.
Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...
Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...