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Gonal-f RFF (Follitropin Alfa Injection) - 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

  1. 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.
  2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
  3. Appropriate evaluation should be performed to exclude pregnancy.
  4. 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.
  5. 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

  1. Before treatment with Gonal-f® is instituted for azoospermia, a thorough medical and endocrinologic evaluation must be performed.
  2. Hypogonadotropic hypogonadism should be confirmed, and primary testicular failure should be excluded by the determination of gonadotropin levels.
  3. Prior to Gonal-f® therapy for azoospermia in patients with hypogonadotropic hypogonadism, serum testosterone levels should be normalized.

See all Gonal-f RFF indications & dosage >>


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

Male Infertility Might Signal Higher Odds of Testicular Cancer
Source: MedicineNet Testicular Cancer Specialty [2015.11.16]
Title: Male Infertility Might Signal Higher Odds of Testicular Cancer
Category: Health News
Created: 11/16/2015 12:00:00 AM
Last Editorial Review: 11/16/2015 12:00:00 AM

New studies question the treatment of female infertility with stem cells
Source: Fertility News From Medical News Today [2015.11.04]
It has been claimed that a treatment for female infertility will be available by stem cell therapy.

For Unexplained Infertility, Breast Cancer Drug No Better Than Standard Treatment
Source: MedicineNet letrozole Specialty [2015.09.24]
Title: For Unexplained Infertility, Breast Cancer Drug No Better Than Standard Treatment
Category: Health News
Created: 9/23/2015 12:00:00 AM
Last Editorial Review: 9/24/2015 12:00:00 AM

Infertility Pictures Slideshow: Which Treatment Is Right for You?
Source: MedicineNet Endometrial Biopsy Specialty [2014.05.01]
Title: Infertility Pictures Slideshow: Which Treatment Is Right for You?
Category: Slideshows
Created: 12/10/2010 5:53:00 PM
Last Editorial Review: 5/1/2014 12:00:00 AM

Source: MedicineNet Celiac Disease Specialty [2013.07.15]
Title: Infertility
Category: Diseases and Conditions
Created: 11/17/2004 12:00:00 AM
Last Editorial Review: 7/15/2013 12:00:00 AM

more news >>

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)

Comparative Pharmacokinetics of AFOLIA and US Gonal-f� RFF Redi-ject After Single Subcutaneous Application [Recruiting]
Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of Afolia.

EXpression PRofile Endometrium Samples Study [Terminated]
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest. The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.

Low-dose Gonal-f in Ovulation Induction [Completed]
This is a prospective, multicenter, open-label, comparative and parallel-group study of ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH) treatment using the Gonal-f prefilled pen in World Health Organization (WHO) Type 2 anovulatory subjects who have previously failed to conceive with clomifene treatment.

Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization [Completed]
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilisation (IVF).

CONSORT Randomized Controlled Trial in Assisted Reproductive Technology [Completed]

more trials >>


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
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!

See all Gonal-F RFF reviews / ratings >>

Page last updated: 2015-11-16

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