GONAL-F RFF SUMMARY
Gonal-f® (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the α- and β-subunits. The α- and β-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. The in vivo biological activity of follitropin alfa has been calibrated against the first International Standard for Recombinant Human Follicle Stimulation Hormone established in 1995 by the Expert Committee on Biological Standards of the World Health Organization. Gonal-f® contains no luteinizing hormone (LH) activity. Based on available data derived from physico-chemical tests and bioassays, follitropin alfa and follitropin beta, another recombinant follicle stimulating hormone product, are indistinguishable.
Gonal-f® (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Selection of Patients
- Before treatment with Gonal-f® is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program.
- Primary ovarian failure should be excluded by the determination of gonadotropin levels.
- Appropriate evaluation should be performed to exclude pregnancy.
- Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Gonal-f® therapy.
- Evaluation of the partner's fertility potential should be included in the initial evaluation.
Gonal-f® (follitropin alfa for injection) is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
Selection of Patients
- Before treatment with Gonal-f® is instituted for azoospermia, a thorough medical and endocrinologic evaluation must be performed.
- Hypogonadotropic hypogonadism should be confirmed, and primary testicular failure should be excluded by the determination of gonadotropin levels.
- Prior to Gonal-f® therapy for azoospermia in patients with hypogonadotropic hypogonadism, serum testosterone levels should be normalized.
Media Articles Related to Gonal-f RFF (Follitropin Alfa Injection)
Researchers identify gene responsible for some cases of male infertility
Source: Fertility News From Medical News Today [2015.07.10]
In about one-sixth of the cases of male infertility, men do not make any measurable levels of sperm, a condition called azoospermia.
Penn team identifies gene responsible for some cases of male infertility
Source: Fertility News From Medical News Today [2015.07.02]
In the most severe form of male infertility, men do not make any measurable levels of sperm.
Study of cholesterol in cells offers clues on infertility and early puberty
Source: Cholesterol News From Medical News Today [2015.06.18]
Cells use cholesterol to make the steroid hormones that trigger puberty and support pregnancy. Now, a new study of this may help find causes of infertility and early puberty.
New mechanism for male infertility discovered
Source: Fertility News From Medical News Today [2015.06.18]
A new study led from Karolinska Institutet in Sweden links male infertility to autoimmune prostatic inflammation. The findings are published in the journal Science Translational Medicine.
Cycling and risk for erectile dysfunction, infertility, prostate cancer
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2014.07.08]
Cycling is a popular activity that offers clear health benefits, but there is an ongoing controversy about whether men who ride have a higher risk of urogenital disorders such as erectile...
Published Studies Related to Gonal-f RFF (Follitropin Alfa Injection)
Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF. [2010.11]
A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH (rFSH) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection...
Safety and efficacy of mixing cetrorelix with follitropin alfa: a randomized study. [2010.06]
OBJECTIVE: To assess the safety and efficacy of mixing cetrorelix with follitropin alfa (rFSH) in assisted reproductive technology...
A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. [2009.12]
BACKGROUND: Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation... CONCLUSION: Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.
Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens. [2008.03]
OBJECTIVE: Ovarian stimulation by injection of gonadotrophins is an essential part of assisted reproductive technology (ART) protocols. Two studies (a German pilot study and an Australian study) aimed to assess and compare the ease-of-use, safety and efficacy of two follitropin injection pens... CONCLUSIONS: Taken together, results from these two small studies suggest that the follitropin alfa pen was effective, well tolerated, and patient and nurse acceptance appeared to be higher for the follitropin alfa pen versus the follitropin beta pen, which may benefit compliance, leading to improved outcomes.
Pharmacodynamics of a single low dose of long-acting recombinant follicle-stimulating hormone (FSH-carboxy terminal peptide, corifollitropin alfa) in women with World Health Organization group II anovulatory infertility. [2004.12]
In a double-blind, placebo-controlled, randomized study, 55 anovulatory subjects received a single s.c... Thus, a single low dose of long-acting FSH-CTP was able to induce one or more follicles to grow up to ovulatory sizes, but the anovulatory status was not reversed because the incidence of subsequent (mono)ovulations was low.
Clinical Trials Related to Gonal-f RFF (Follitropin Alfa Injection)
Predictive Factors of Ovarian Response in Ovulation Induction With Intrauterine Insemination of a Gonal-f Low-dose Regimen [Recruiting]
This is a multicentric, prospective, observational study on the use of Gonal-f in controlled
ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine
insemination (OI/IUI) therapy across Taiwan. It has been observed in the previous studies
that COH with follicle stimulating hormone (FSH) is considered as one of the positive
predictors of an ongoing pregnancy. Many studies in the past have tried to predict the FSH
threshold, defined as the FSH dose on the day when a follicle is >10 mm in diameter, but no
studies have been conducted to date to determine the predictive factors for a monofollicular
development after COH in IUI cycles. Monofollicular growth contributes significantly to the
reduction of multiple pregnancies and thus minimize the risks associated with such
pregnancies. This study would provide preliminary data on the factors associated with a
monofollicular development in Gonal-f treated cycles using a low dose step-up regimen.
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 [Recruiting]
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.
Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction [Recruiting]
This is an open-label, prospective, randomised, controlled, multicentric, multinational,
phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with
chronic anovulation. It has been observed that conventional high dose set up regimen of
gonadotropin and human chorionic gonadotropin (hCG) is effective in anovulatory subjects in
terms of overall pregnancy rates. However, development of multiple follicles leading to
multiple pregnancy and/or ovarian hyperstimulation syndrome (OHSS) are the major
complications associated with this high dose set up. Chronic low-dose (CLD) protocols of
follicle stimulating hormone (FSH), aimed at finding the threshold amount of FSH necessary
to promote monofolliculogenesis, have been found to be successful in reducing the rate of
OHSS almost to nil and the rate of multiple pregnancies to a minimum. This post-marketing
study will investigate tailoring of recombinant FSH in a large population (N=300) of
subjects from a region (North Africa/Middle East) that has not been included in previous
studies of ovulation induction in subjects with chronic anovulation. The study aims to
increase current knowledge of the efficacy and safety of Gonal-f, and provide fertility
physicians with experience in Gonal f treatment in anovulatory infertility, thereby
contributing to the development of FSH dosing guidelines for ovulation induction by defining
the optimal CLD and Low dose( LD) regimens.
GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment) [Recruiting]
This non-interventional study (NIS) is planned to examine the consistency of the dose
recommended by the doctor for the first stimulation day with the dose recommended by the
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment [Recruiting]
Ther purpose of this study is to show equivalence with regard to the number of oocytes
retrieved between AFOLIA and Gonal-f® in women for assisted reproductive treatment
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Gonal-F RFF has an overall score of 9. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
Gonal-F RFF review by 44 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || increase follicle production prior to iui|
|Dosage & duration:|| || 175 units injected of 900mg daily taken daily days 3-9 of cycle for the period of 2 cycles|
|Other conditions:|| || none|
|Other drugs taken:|| || ovidrel|
|Benefits:|| || Produced mature follicles for iui cycle.|
|Side effects:|| || Very mild burning sensation in abdomen, NO problem with injection - very easy to use pen.|
|Comments:|| || Used gonal-f on cycles days 3-7 to aid in producing mature follicles for iui. Drug was successful and had no complications. Would use it again if I needed to!|
Page last updated: 2015-07-10