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Follistim (Follitropin Beta) - Summary

 
 



FOLLISTIM SUMMARY

Follistim® (follitropin beta for injection) contains human follicle-stimulating hormone (hFSH), a glycoprotein hormone which is manufactured by recombinant DNA (rDNA) technology.

Follistim® (follitropin beta for injection) is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follistim® is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Selection of Patients

Before treatment with Follistim® is instituted:

  1. A thorough gynecologic and endocrinologic evaluation of the patient must be performed. The evaluation should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of reviewing a patient's history, performing a physical examination, determining serum hormonal levels as indicated, and optionally performing an endometrial biopsy. Patients with tubal pathology should receive Follistim® only if enrolled in an ART program.
  2. Primary ovarian failure should be excluded by the determination of circulating gonadotropin levels.
  3. Careful examination should be made to rule out early pregnancy.
  4. Evaluation of the partner's fertility potential should be included in the workup procedure.

See all Follistim indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Follistim (Follitropin Beta)

Premature Hardening Of The Zona Pellucida Can Be A Cause Of Infertility
Source: Fertility News From Medical News Today [2013.04.26]
Scientists in Mainz and Aachen have discovered a new mechanism that controls egg cell fertility and that might have future therapeutic potential. It was revealed by Professor Dr. Walter Stocker of the Institute of Zoology at Johannes Gutenberg University Mainz (JGU) that the blood protein fetuin-B plays an important and previously unknown role in the fertilization of oocytes...

Infertility: Ten Infertility Questions to Ask Your Doctor
Source: MedicineNet Uterine Growths Specialty [2012.05.21]
Title: Infertility: Ten Infertility Questions to Ask Your Doctor
Category: Doctor's Views
Created: 6/21/2005 12:00:00 AM
Last Editorial Review: 5/21/2012 12:00:00 AM

Infertility Pictures Slideshow: Which Treatment Is Right for You?
Source: MedicineNet Turner Syndrome Specialty [2011.10.20]
Title: Infertility Pictures Slideshow: Which Treatment Is Right for You?
Category: Slideshows
Created: 12/10/2010 5:53:00 PM
Last Editorial Review: 10/20/2011 12:00:00 AM

Infertility
Source: MedicineNet Turner Syndrome Specialty [2009.07.29]
Title: Infertility
Category: Diseases and Conditions
Created: 11/17/2004 12:00:00 AM
Last Editorial Review: 7/29/2009 12:00:00 AM

Female Adults Lack Stem Cells For Making New Eggs
Source: Fertility News From Medical News Today [2013.05.01]
Mammalian females ovulate periodically over their reproductive lifetimes, placing significant demands on their ovaries for egg production. Whether mammals generate new eggs in adulthood using stem cells has been a source of scientific controversy. If true, these "germ-line stem cells" might allow novel treatments for infertility and other diseases...

more news >>

Published Studies Related to Follistim (Follitropin Beta)

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...

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.

The effect of cetrorelix vs. ganirelix on pregnancy outcome using minimal gonadotropin stimulation in women with elevated day 3 serum follicle stimulating hormone levels. [2009]
CONCLUSIONS: The trend for lower pregnancy rates with ganirelix vs. cetrorelix seen in women with diminished egg reserve is consistent with the findings of a study performed in women with normal egg reserve using a normal gonadotropin stimulation regimen. It is not clear if the adverse effect is on the endometrium or the embryo.

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.

Comparison of the efficacy and safety of a new recombinant human follicle-stimulating hormone (DA-3801) with follitropin-alpha (Gonal-F((R))) in women undergoing controlled ovarian hyperstimulation for assisted reproductive technology. [2007.06]
Aim: To compare the efficacy and safety of a new recombinant human follicle-stimulating hormone (FSH; DA-3801) with follitropin-alpha (Gonal-F((R))) in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive technology (ART)... Other secondary efficacy endpoints, including pregnancy and implantation rates and the incidence and severity of adverse events, were comparable between the two groups.

more studies >>

Clinical Trials Related to Follistim (Follitropin Beta)

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.

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.

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

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Follistim has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Follistim review by 35 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Infertility
Dosage & duration:   50-100 units (dosage frequency: 6 cycles) for the period of 6 cycles
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I got pregnant.
Side effects:   One of the cycles yielded like 3-4 good follicles which I thought were too much but took the risk anyway.
Comments:   One of the cycles yielded like 3-4 good follicles which I thought were too much but took the risk anyway. Puregon is very easy and PLEASANT to use, nothing I had expected. It is very straight forward, or "Idiot Proof". Did not hurt did not burn.

See all Follistim reviews / ratings >>

Page last updated: 2013-05-01

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