The recombinant human chorionic gonadotropin prefilled pen: results of patient and nurse human factors usability testing.

Objectives: The first prefilled pen for administration of recombinant human chorionic gonadotropin (r-hCG) has been developed. Usability testing was undertaken to evaluate the risk of dosing errors versus the existing r-hCG prefilled syringe, and assess function and handling of the pen.

Methods: Infertile women who were trying to conceive, and specialist nurses, were recruited in Germany.

The redesigned follitropin alfa pen injector: results of the patient and nurse human factors usability testing.

Objectives: A redesigned pen injector for administration of follitropin alfa (follitropin α) has been developed for use in fertility treatment cycles. Pre-summative and summative usability testing was undertaken to assess the risk of dosing errors compared with the existing follitropin α pen. The study also assessed proper use of and dose selection with the redesigned pen.

The redesigned follitropin α pen injector for infertility treatment.

Introduction: Treatment for infertility may require multiple drugs and complex dosing schedules. Available injection devices for patients who require regular injections during treatment are reviewed in this article, focusing on pen injectors used to self-administer recombinant human follicle-stimulating hormone (follitropin α). Following the introduction of the first and second follitropin α pen injectors in the last decade, a third pen injector with improved design for the administration of follitropin α has been developed for use in fertility treatment cycles.

Midluteal serum progesterone levels and pregnancy following ovulation induction with human follicle-stimulating hormone: results of a combined-data analysis.

Objective: This retrospective analysis of combined data (one Phase II and three Phase III clinical trials) of patients with oligo- or anovulatory infertility aimed to evaluate the association between pregnancy and midluteal serum progesterone (P4) level following ovulation induction and hence the indicative value of P4 for ovulation and pregnancy achievement.

Study Design: All patients (n = 913) were treated with human follicle-stimulating hormone. Cycles (n = 1,554) with one or two serum P4 levels in the luteal phase (days 5-12) following human chorionic gonadotropin administration and complete data on cycle outcome were included.

Anastrozole versus clomiphene citrate: which is better for ovulation induction?

Although anastrozole may be used as an oral therapeutic agent in ovulation induction, it is not recommended as a replacement for clomiphene citrate. On the basis of two phase 2 studies, anastrozole should be viewed as a second-tier therapy after clomiphene citrate in anovulatory patients.

Anastrozole single-dose protocol in women with oligo- or anovulatory infertility: results of a randomized phase II dose-response study.

Objective: To compare the effects of anastrozole and clomiphene citrate (CC) on follicular development and ovulation in infertile women with ovulatory dysfunction.

Design: Phase II, prospective, randomized, assessor-blind, multicenter, dose-finding, noninferiority study.

Setting: Outpatient.

Anastrozole vs. clomiphene citrate in infertile women with ovulatory dysfunction: a phase II, randomized, dose-finding study.

Objective: To determine an effective multiple-dose regimen of anastrozole compared with clomiphene citrate (CC) to induce follicular growth and ovulation in infertile women with ovulatory dysfunction.

Design: Phase II, prospective, randomized, double-blind, multicenter, dose-finding, noninferiority study.

Setting: Outpatient.

Recombinant human follicle-stimulating hormone produces more oocytes with a lower total dose per cycle in assisted reproductive technologies compared with highly purified human menopausal gonadotrophin: a meta-analysis.

Background: Human menopausal gonadotrophins and recombinant human follicle stimulating hormone are the two main gonadotrophin products utilized for controlled ovarian stimulation in assisted reproductive technologies. In this meta-analysis, the number of oocytes was designated as the most relevant endpoint directly resulting from ovarian stimulation, and therefore where the drug effect may be estimated with the best sensitivity.

Methods: All published randomized controlled trials on ovarian stimulation comparing the two gonadotrophin products were evaluated.

A comparison of menotropin, highly-purified menotropin and follitropin alfa in cycles of intracytoplasmic sperm injection.

Background: Over the last several decades, as a result of an evolution in manufacturing processes, a marked development has been made in the field of gonadotropins for ovarian stimulation. Initially, therapeutic gonadotropins were produced from a simple process of urine extraction and purification; now they are produced via a complex system involving recombinant technology, which yields gonadotropins with high levels of purity, quality, and consistency.

Methods: A retrospective analysis of 865 consecutive intracytoplasmic sperm injection (ICSI) cycles of controlled ovarian hyperstimulation (COH) compared the clinical efficacy of three gonadotropins (menotropin [hMG; n = 299], highly-purified hMG [HP-hMG; n = 330] and follitropin alfa [r-hFSH; n = 236]) for ovarian stimulation after pituitary down-regulation.

Luteal phase bleeding after IVF cycles: comparison between progesterone vaginal gel and intramuscular progesterone and correlation with pregnancy outcomes.

Background: To compare luteal phase bleeding and pregnancy outcomes in normogonadotropic patients receiving progesterone vaginal gel (PVG) or intramuscular progesterone (IMP) injections.

Methods: In this retrospective cohort study, data from 270 patients (292 cycles) undergoing day-3 fresh embryo transfer were analyzed. PVG, 90 mg daily (170 cycles) or IMP, 50 mg daily (122 cycles) began at egg retrieval.

Patients' return to referring physicians and its relation to their infertility duration.

Objective: To determine if length of patient-reported infertility prior to referral to a specialist is related to the likelihood that the patient will return to the referring physician for obstetrical care.

Methods: A review of our medical record database identified 430 consecutive pregnant patients, discharged between January 1, 2003, and March 1, 2004. The name of the referring and discharge obstetrician(s), duration of infertility, prior use of clomiphene citrate, and number of previous clomiphene treatment cycles were recorded.

Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women.

Objective: To evaluate patient satisfaction with the follitropin alfa prefilled pen (Gonal-f RFF Pen), compared with previously used injectable gonadotropins (vial/ampoules and syringe), in women undergoing ovulation induction (OI).

Research Design And Methods: Women aged 18-40 years undergoing OI for oligoanovulatory infertility were enrolled from nine US fertility centers in this prospective, open-label clinical trial. Participants received recombinant follitropin alfa using a prefilled pen.