The performance of the different commercial antimullerian hormone assays for polycystic ovary syndrome diagnosis is comparable, but different threshold values should be used for automatic and manual assays.
Pascal Pigny, Ph.D., Elisse Gorisse, M.D., Amjad Ghulam, M.D., Geoffroy Robin, M.D., Sophie Catteau-Jonard, M.D., Ph.D., Alain Duhamel, M.D., Ph.D., Didier Dewailly, M.D.
Volume 105, Issue 4, Pages 1063-1069
To determine whether the different antimüllerian hormone (AMH) immunoassays on the market offer the same performance for the diagnosis of polycystic ovary syndrome (PCOS).
A total of 95 serum AMH samples were retrospectively evaluated for a period of 3 months in the same laboratory.
Academic center laboratory.
Forty-eight control women with regular menses and no hyperandrogenism and 47 patients with classic PCOS (i.e., hyperandrogenism plus oligoanovulation) attending our department for infertility.
Main Outcome Measure(s):
AMH measurement using five commercial assays. Method comparison and evaluation of the diagnostic performance by receiver operating characteristic analysis.
Values obtained with Gen II and AL-105i ELISAs were similar to those provided by EAI AMH/MIS, whereas automatic assays generated lower values. A significant mean difference was observed between Access Dxi (1.35 ng/mL) or Cobas (1.73 ng/mL) and EIA AMH/MIS ELISA. By ROC analysis each assay displayed similar efficiency for PCOS diagnosis. Sensitivities varied from 49% to 74% when setting the specificity at 92%. Cluster analysis run in the control group identified a subgroup of asymptomatic women with polycystic ovary morphology (PCOM). After exclusion of PCOM, the 95th percentile of controls was 4.2 ng/mL (30 pmol/L) with the automatic assays and 5.6 ng/mL (40 pmol/L) with the manual assays.
Performance of the different AMH assays for PCOS diagnosis is comparable, providing that different threshold values are used for manual and automatic assays. Measurement of serum AMH level appears as a robust tool for the definition of PCOM.
Oral administration of an FSH agonist demonstrated acceptable exposure and was well tolerated. No clear effect was observed on follicular development; higher doses were not tested owing to thyroid function test changes.
Mireille G.F. Gerrits, Pharm.D., Hester Kramer, Ph.D., Rachid el Galta, Ph.D., Geertje van Beerendonk, Ph.D., Robert Hanssen, Ph.D., Khalid Abd-Elaziz, M.D., Christine Klipping, M.D., Ph.D., Ingrid Duijkers, M.D., Ph.D., S. Aubrey Stoch, M.D.
Volume 105, Issue 4, Pages 1056-1062
To assess the safety, pharmacokinetics, and pharmacodynamics of MK-8389.
Double-blind, placebo-controlled, parallel-group, ascending dose study.
Two clinical research organizations.
Healthy young women.
Once-daily oral doses of MK-8389 or placebo for 14 days.
Main Outcome Measure(s):
Safety, including thyroid function tests (TFTs), pharmacokinetics, and follicular development (follicle size and number and serum E2 and inhibin B levels).
Treatment with MK-8389 was generally safe and well tolerated. An effect on TFTs was observed, which was transient and did not lead to clinical signs or symptoms but prevented dose escalation above 40 mg. MK-8389 was rapidly absorbed, slowly eliminated, and showed a large peak-to-trough ratio. No clinically meaningful effect was seen on follicle size and numbers, which was consistent with the low E2 levels. At doses >20 mg, inhibin B levels were increased, suggesting early follicular development at higher doses.
Oral administration of MK-8389 demonstrated acceptable systemic exposure and was generally well tolerated. This study failed to demonstrate a clinically meaningful effect of MK-8389 on follicular development, whereas MK-8389 unexpectedly affected thyroid function. This study did not explore doses above 40 mg given the changes observed in TFTs, which may relate to high MK-8389 peak concentrations.
Clinical Trial Registration Number:
EudraCT Number 2010-022396-57.
Kelly A. Chiles, M.D., Peter N. Schlegel, M.D.
Volume 105, Issue 4, Pages 891-892
Microsurgical reconstruction for male infertility is a relatively recent development in the history of urology therapy. The results of the first microsurgical vasovasostomy (VV) were published in the late1960s, and this epic achievement has been followed by almost fifty years of microsurgical innovation (1). Despite the well-established success of microsurgery, the role of male reproductive tract reconstruction has been called into question because of the many advances made in assisted reproductive technology (ART).
Kelly A. Chiles, M.D., Peter N.…
This document provides updated coding information for services related to assisted reproductive technology procedures.…