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Gonal-f RFF (Follitropin Alfa Injection) - Summary

 
 



GONAL-F RFF SUMMARY

Gonal-f® RFF Pen
(follitropin alfa injection)
*revised formulation female
For subcutaneous injection

Gonal-f RFF (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 stimulating hormone established in 1995 by the Expert Committee on Biological Standards of the World Health Organization. Gonal-f RFF 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 RFF (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f RFF is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.


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NEWS HIGHLIGHTS

Media Articles Related to Gonal-f RFF (Follitropin Alfa Injection)

For Infertility Treatment, Should He Drink Less Coffee, More Booze?
Source: MedicineNet Nutrition Specialty [2014.10.21]
Title: For Infertility Treatment, Should He Drink Less Coffee, More Booze?
Category: Health News
Created: 10/20/2014 12:00:00 AM
Last Editorial Review: 10/21/2014 12:00:00 AM

Ovarian tissue and egg freezing should be made widely available to prevent age-related infertility, say leading fertility experts
Source: Fertility News From Medical News Today [2014.10.03]
Ovarian tissue and egg freezing to preserve fertility should no longer be reserved for cancer patients, and healthy women should also be offered these options to safeguard their future chances of...

Infertility: Ten Questions to Ask Your Doctor About Infertility
Source: MedicineNet Endometriosis Specialty [2014.09.12]
Title: Infertility: Ten Questions to Ask Your Doctor About Infertility
Category: Doctor's & Expert's views on Symptoms
Created: 6/21/2005 12:00:00 AM
Last Editorial Review: 9/12/2014 12:00:00 AM

Rare stem cells identified in testis hold potential for infertility treatments
Source: Fertility News From Medical News Today [2014.09.09]
Rare stem cells in testis that produce a biomarker protein called PAX7 help give rise to new sperm cells - and may hold a key to restoring fertility, research by scientists at UT Southwestern Medical...

Surge in infertility treatments led by white, heterosexual women
Source: Fertility News From Medical News Today [2014.08.20]
Heterosexual white women are twice as likely as racial or sexual minority women to obtain medical help to get pregnant, according to a recent study published by the American Psychological Association.

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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.

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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.

A Phase III Study to Compare Efficacy and Safety of AFOLIA vs. Gonal-f� in Infertile Women 35 to 42 Years of Age Undergoing in Vitro Fertilization (IVF) [Not yet recruiting]
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to the widely used and marketed r-hFSH Gonal-f.

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 CONSORT calculator.

more trials >>


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

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
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
  
Reported Results
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!

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Page last updated: 2014-10-21

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