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Background and Objectives Optical coherence tomography (OCT) permits high-resolution imaging of tissue subsurfaces up to 2 mm in depth. The purpose of this study was to evaluate the accuracy and reproducibility of OCT in the characterization of cervical intraepithelial neoplasia (CIN) and to distinguish between different CIN grades. Study Design/Materials and Methods Colposcopy-guided OCT images were taken from unsuspicious and suspicious areas in women with suspected CIN. Each woman then underwent directed biopsies. All OCT images were separately evaluated by two blinded investigators and later compared to the corresponding histology based on a 6-grade classification (normal, inflammation, CIN 1, CIN 2, CIN 3, squamous carcinoma). Sensitivity and specificity of OCT in detecting CIN were determined. To assess the interobserver agreement, kappa coefficients were calculated from the ratings of each investigator for each OCT image seen. Results A total of 210 OCT images were compared with the corresponding histology in 120 women undergoing colposcopy for suspected CIN. Sensitivity calculated for both investigators was 98% and 96% respectively with the threshold at CIN1 and 86% and 84% respectively with the threshold at CIN2. Thirty nine (38) false positive results reduced the specificity to 39% and 41% respectively with the threshold at CIN1. Defining the threshold at CIN2 the specificity increased to 64% and 60% respectively. Unweighted kappa from a dichotomous classification with the threshold at CIN1 was 0.69 (95% CI, 0.54–0.84) and 0.62 (95% CI, 0.51–0.73) with the threshold at CIN2. Conclusion OCT is highly sensitive in identifying pre-invasive and invasive cancer of the uterine cervix. Improvements in resolution and the development of new light sources and optics may improve the specificity as well as the differentiation of cervical dysplasia. The interobserver agreement was substantial. Lasers Surg. Med. 43:206–212, 2011. © 2011 Wiley-Liss, Inc.

A multicenter, open-label, randomized efficacy and safety study was performed with combined human chorionic gonadotropin (hCG) and recombinant follicle-stimulating hormone (recFSH) (Puregon(R)) treatment to induce spermatogenesis in hypogonadotropic hypogonadal male patients. Patients were pretreated for 16 weeks with hCG to normalize testosterone levels. A total of 30 of 49 (61%) subjects had normalized testosterone levels but were still azoospermic after the hCG-alone phase. These patients were randomized into 2 treatment schemes with recFSH (2 x 225 IU recFSH per week [group A] or 3 x 150 IU recFSH per week [group B]), in combination with hCG for a period of 48 weeks. Total testosterone increased during the hCG-alone period from 1.08 and 1.22 ng/mL to 6.26 and 4.52 ng/mL for groups A and B, respectively. Combined gonadotropin treatment was effective in inducing spermatogenesis (sperm count >/=1 x 10(6)/mL) in 14 of 30 subjects (47%) and this was achieved after a median duration of treatment of approximately 5.5 months. Treatment time necessary for first sperm cells to appear in the ejaculate was related to the initial testicular volume. Subjects with a history of maldescended testes (11 of 30 subjects, 37%) showed a lower mean response to treatment as indicated by the relatively lower number of subjects reaching levels of at least 1 x 10(6) sperm cells per milliliter. Combined testicular volume increased during combined gonadotropin treatment from 11.4 to 24.0 mL. Although subjects with a history of maldescended testes had a lower starting testicular volume, subjects with and without a history of maldescended testes showed approximately the same relative increase in testicular volume. Total testosterone levels showed only a minor further increase during the combined gonadotropin treatment period. In conclusion, a weekly dose of 450 IU (3 x 150 IU or 2 x 225 IU) recFSH, in addition to hCG, was able to induce spermatogenesis in many hypogonadotropic azoospermic men who failed to respond to treatment with hCG alone.

Objective To establish and validate an ex vivo human cervical tissue model for optical coherence tomography (OCT) studies with special emphasis on investigating time dependent structural changes of the epithelium. Methods Four hundred OCT images were taken from 80 unsuspicious and suspicious areas of 18 fresh conisation specimens immediately after resection (0 hour) and 1, 2, 3, and 4 hours, referred to as waiting times in the following, postoperatively and compared to the corresponding histology. For each 2D-OCT-image, a 1D-intensity profile was generated. The profiles were analyzed with respect to systematic differences which may result from different waiting times, employing discriminant analysis (DA). Results The different waiting times do not appear to imply significant differences among the corresponding OCT-images as represented by the intensity profiles. Conclusion We conclude that the proposed cervical tissue model appears to be applicable for ex vivo OCT studies. Lasers Surg. Med. 44:245–248, 2012. © 2012 Wiley Periodicals, Inc.

Optical coherence tomography (OCT) permits high-resolution imaging of tissue subsurfaces up to 2 mm in depth. The purpose of this study was to evaluate the accuracy and reproducibility of OCT in the characterization of cervical intraepithelial neoplasia (CIN) and to distinguish between different CIN grades.Colposcopy-guided OCT images were taken from unsuspicious and suspicious areas in women with suspected CIN. Each woman then underwent directed biopsies. All OCT images were separately evaluated by two blinded investigators and later compared to the corresponding histology based on a 6-grade classification (normal, inflammation, CIN 1, CIN 2, CIN 3, squamous carcinoma). Sensitivity and specificity of OCT in detecting CIN were determined. To assess the interobserver agreement, kappa coefficients were calculated from the ratings of each investigator for each OCT image seen.A total of 210 OCT images were compared with the corresponding histology in 120 women undergoing colposcopy for suspected CIN. Sensitivity calculated for both investigators was 98% and 96% respectively with the threshold at CIN1 and 86% and 84% respectively with the threshold at CIN2. Thirty nine (38) false positive results reduced the specificity to 39% and 41% respectively with the threshold at CIN1. Defining the threshold at CIN2 the specificity increased to 64% and 60% respectively. Unweighted kappa from a dichotomous classification with the threshold at CIN1 was 0.69 (95% CI, 0.54-0.84) and 0.62 (95% CI, 0.51-0.73) with the threshold at CIN2.OCT is highly sensitive in identifying pre-invasive and invasive cancer of the uterine cervix. Improvements in resolution and the development of new light sources and optics may improve the specificity as well as the differentiation of cervical dysplasia. The interobserver agreement was substantial.