Economic evaluation of highly purified human menotropin or recombinant follicle-stimulating hormone for controlled ovarian stimulation in high-responder patients: analysis of the Menopur in Gonadotropin-releasing Hormone Antagonist Single Embryo Transfer-High Responder (MEGASET-HR) trial.

Objective: To determine the cost of achieving a live birth after first transfer using highly purified human menotropin (HP-hMG) or recombinant follicle-stimulating hormone (FSH) for controlled ovarian stimulation in predicted high-responder patients in the Menopur in Gonadotropin-releasing hormone Antagonist Single Embryo Transfer-High Responder (MEGASET-HR) trial.

Design: Cost minimization analysis of trial results.

Setting: Thirty-one fertility centers.

Validation study of the Access antimüllerian hormone assay for the prediction of poor ovarian response to controlled ovarian stimulation.

Objective: To evaluate the diagnostic performance of the antimüllerian hormone (AMH) level determined using the Access AMH assay for predicting poor ovarian response (POR) defined as ≤4 oocytes retrieved, including the validation of the predefined AMH cutoff of 0.93 ng/mL in both serum and plasma.

Design: Prospective cohort study.

A multi-centre international study of salivary hormone oestradiol and progesterone measurements in ART monitoring.

Research Question: Ovarian stimulation during IVF cycles involves close monitoring of oestradiol, progesterone and ultrasound measurements of follicle growth. In contrast to blood draws, sampling saliva is less invasive. Here, a blind validation is presented of a novel saliva-based oestradiol and progesterone assay carried out in samples collected in independent IVF clinics.

Types and frequency of non-conformances in an IVF laboratory.

Study Question: How many non-conformances occur in an ART laboratory and how often do they occur?

Summary Answer: The limited data to date demonstrate that IVF laboratories have a very low non-conformance rate compared with reported non-conformances in other medical laboratories, especially when one considers the high-complexity of procedures performed.

What Is Known Already: ART involves a series of very complex patient and laboratory procedures. Although it is assumed that strict measures control ART laboratories, there is very little published data on non-conformances.

Multicenter evaluation of the Access AMH antimüllerian hormone assay for the prediction of antral follicle count and poor ovarian response to controlled ovarian stimulation.

Objective: To evaluate a new fully automated antimüllerian hormone (AMH) assay for prediction of poor ovarian response (POR) to ovarian stimulation defined as four or fewer oocytes retrieved.

Design: Prospective cohort study.

Setting: Thirteen private and academic fertility centers in the United States.

Ovarian stimulation protocols for IVF: is more better than less?

Conventional ovarian stimulation protocols for IVF are designed to achieve maximum oocyte yields. Conventional protocols, however, are associated with patient discomfort, increased risk of ovarian hyperstimulation syndrome and higher costs. In recent years, mild stimulation protocols have risen in popularity.

How many oocytes are optimal to achieve multiple live births with one stimulation cycle? The one-and-done approach.

Objective: To study how many infertility patients would complete an average-sized family (achieve ≥2 live births) after a single, complete in vitro fertilization (IVF) cycle.

Design: A retrospective cohort study.

Setting: University-affiliated private infertility practice.

When is clomiphene or gonadotropin intrauterine insemination futile? Results of the Fast Track and Standard Treatment Trial and the Forty and Over Treatment Trial, two prospective randomized controlled trials.

Objective: To determine whether day 3 FSH and E2 levels at the upper limits of normal affect live-birth rates and treatment trajectory in a conventional versus "fast track" treatment program for IVF.

Design: Secondary analysis of two randomized controlled trials, FASTT and FORT-T.

Setting: Not applicable.

A randomized clinical trial to determine optimal infertility treatment in older couples: the Forty and Over Treatment Trial (FORT-T).

Objective: To determine the optimal infertility therapy for women at the end of their reproductive potential.

Design: Randomized clinical trial.

Setting: Academic medical centers and private infertility center in a state with mandated insurance coverage.

Experience with ISO quality control in assisted reproductive technology.

Assisted reproductive technology (ART) programs are complex organizations requiring the integration of multiple disciplines. ISO 9001:2008 is a quality management system that is readily adaptable to an ART program. The value that ISO brings to the entire organization includes control of documents, clear delineation of responsibilities of staff members, documentation of the numerous processes and procedures, improvement in tracking and reducing errors, and overall better control of systems.

Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF.

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. This double-blind randomized controlled trial assessed the pharmacokinetics and pharmacodynamics of 150 μg corifollitropin alfa versus daily 200 IU rFSH in 1509 patients. Comparative analyses were performed on serum concentrations of FSH immunoreactivity (pharmacokinetics), and the number and size of growing follicles, and inhibin B and oestradiol concentrations as biomarkers of ovarian response (pharmacodynamics).

Impact of a group mind/body intervention on pregnancy rates in IVF patients.

Objective: To determine if women who were randomized to a mind/body program before starting their first IVF cycle would have higher pregnancy rates than control subjects.

Design: Randomized, controlled, prospective study.

Setting: Private academically affiliated infertility center.

Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF.

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. This double-blind randomized controlled trial assessed the pharmacokinetics and pharmacodynamics of 150μg corifollitropin alfa versus daily 200IU rFSH in 1509 patients. Comparative analyses were performed on serum concentrations of FSH immunoreactivity (pharmacokinetics), and the number and size of growing follicles, and inhibin B and oestradiol concentrations as biomarkers of ovarian response (pharmacodynamics).

A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial.

Objective: To determine the value of gonadotropin/intrauterine insemination (FSH/IUI) therapy for infertile women aged 21-39 years.

Design: Randomized controlled trial.

Setting: Academic medical center associated with a private infertility center.

Ovarian reserve screening in infertility: practical applications and theoretical directions for research.

The concept of ovarian reserve describes the natural oocyte endowment and is closely associated with female age, which is the single most important factor influencing reproductive outcome. Fertility potential first declines after the age of 30 and moves downward rapidly thereafter, essentially reaching zero by the mid-40s. Conceptions beyond this age are exceedingly rare, unless oocytes obtained from a younger donor are utilised.

Ovarian hyperstimulation syndrome: current views on pathophysiology, risk factors, prevention, and management.

Objective: To summarize current views on the pathophysiology, risk factors, prevention, clinical features, and management of Ovarian Hyperstimulation Syndrome (OHSS).

Design: Literature review

Results: OHSS is a condition characterized by increased capillary permeability, and experimental evidence has identified a provocative link to pathologic vasoactive cytokine actions. Although the ultimate physiologic mechanism of OHSS is not yet known, there are well-known risk factors that must be considered during the administration of medications to treat infertility.

Patients with severe ovarian hyperstimulation syndrome can be managed safely with aggressive outpatient transvaginal paracentesis.

Objective: To describe our experience with aggressive outpatient transvaginal paracentesis to manage ovarian hyperstimulation syndrome (OHSS).

Design: Retrospective case series.

Setting: Private, academically affiliated IVF center.

Oral contraceptive pretreatment in women undergoing controlled ovarian stimulation in ganirelix acetate cycles may, for a subset of patients, be associated with low serum luteinizing hormone levels, reduced ovarian response to gonadotropins, and early pregnancy loss.

Oral contraceptive pretreatment facilitated scheduling of pure FSH/GnRH antagonist cycles but in a small subset of patients was associated with low serum LH levels, reduced ovarian response, and early pregnancy loss. Supplementation with LH could be examined as a possible way to improve cycle outcome.

Pregnancy loss in the first in vitro fertilization cycle is not predictive of subsequent delivery in women over 40 years.

Objective: To determine if there is an association between first IVF cycle outcome and subsequent delivery rate for women over 40 years.

Design: Retrospective data analysis.

Setting: Large, private academically affiliated IVF center.

One last chance for pregnancy: a review of 2,705 in vitro fertilization cycles initiated in women age 40 years and above.

Objective: To describe live birth rates and predictors of success in 1-year age increments for women > or =40 years when initiating assisted reproductive technologies (ART).

Design: Retrospective database analysis.

Setting: A large university-affiliated infertility center.

A mesothelial cyst of the round ligament presenting as an inguinal hernia after gonadotropin stimulation for in vitro fertilization.

Objective: To report the case of a round ligament cyst which, as the result of gonadotropin stimulation for IVF, simulated an incarcerated inguinal hernia.

Design: Case report.

Setting: A private infertility center and a university hospital.

Initiation of the gonadotropin-releasing hormone antagonist ganirelix for in vitro fertilization cycles in which the lead follicle is >14 mm.

The initiation of GnRH antagonists when the lead follicle is >14 mm does not adversely affect IVF success rates and leads to a shortened duration of GnRH antagonist administration.

In vitro fertilization outcomes: why doesn't anyone get it?

It is not only patients who frequently do not understand the implications of multiple pregnancies and IVF outcomes in general. Physicians, insurers, and governments must share the responsibility for failing to properly address both overall and multiple pregnancy rates after IVF.

Luteal support with vaginal micronized progesterone gel in assisted reproduction.

The purpose of this study was to review the rationale for vaginal progesterone treatment as luteal support in IVF, and the clinical experience with vaginal micronized progesterone gel. It was found that luteal support with exogenous progesterone significantly improves implantation and pregnancy rates after IVF. Vaginal administration offers a number of potential advantages over intramuscular injection in terms of tolerability and convenience.