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INTRODUCTION: Estimating accurate testicular volume (TV) of congenital hypogonadotropic hypogonadism (CHH) individuals is challenging due to the typically small testicular size. Ultrasound (USG) emerges as a vital solution, enabling precise measurements and reproducible results. The purpose of the study was to assess the three-dimensional measurement of the testis using USG and its volume was estimated using Ellipsoid (E) and Lambert (L) formulae and compared these with the TV by Prader orchidometer (OrTV). METHODS: This is an exploratory analysis of data taken from a clinical trial conducted from May 2022 to March 2024 which included 94 testes from 47 CHH participants. The OrTVs and USGTVs were assessed at baseline and every three months till the completion of the study making a total of 348 observations. The three-dimensional measurement of the testes was noted and TVs were calculated using the above formulae. RESULTS: The mean age of the participants was 25.8 ± 6.14 years with a mean height of 169.9 ± 8.42 cm and body mass index (BMI) of 22.4 ± 4.72 kg/m2. The baseline mean OrTV, USGTV(E) and USGTV(L) were 2.15 ± 0.79 ml, 0.69 ± 0.43 ml and 0.93 ± 0.59 ml respectively. The smallest OrTV observed was 1 ml with its respective mean USGTV of 0.41 ± 0.2 ml(E) and 0.56 ± 0.27 ml(L). An OrTV of 4 ml had a mean USGTV of 1.11 ± 0.42 ml(E) and 1.51 ± 9.57 ml(L). At spermatogenesis, the mean OrTV was 8.84 ± 3.13 ml with the USGTV determined to be 4 ± 1.46 ml(E) and 5.46 ± 1.99 ml(L). CONCLUSION: The study revealed that all CHH patients at diagnosis had OrTV < 4 ml. This corresponds to a USG TV cut-off of 1.11 ml using the Ellipsoid formula and 1.51 ml with the Lambert formula, which could serve as a USG diagnostic criterion for CHH.
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OBJECTIVE: In male congenital hypogonadotropic hypogonadism (CHH), it was observed that lower dose human gonadotropic hormone (hCG) can maintain normal intratesticular testosterone levels. We propose this study to compare the low-dose hCG, follicle stimulating hormone (FSH), and Testosterone (T) [LFT Regimen] to conventional treatment to induce virilization and fertility. DESIGN: This open-label randomized pilot study was conducted from June 2020 to December 2021. SUBJECTS AND OUTCOME MEASURES: CHH were randomly assigned to either the LFT regimen (Group A)-low-dose hCG (500U thrice per week), FSH (150U thrice per week), and T(100 mg biweekly) or conventional therapy(GroupB) with high hCG dose(2000U thrice per week) and the same FSH dose. The hCG dosage was titrated to reduce anti-mullerian hormone (AMH) by 50% and normalization of plasma T in groups A and B, respectively. The primary objective was to compare the percentage of individuals who achieved spermatogenesis between the two groups. RESULTS: Out of 30 patients, 23 (76·7%) subjects achieved spermatogenesis, and the median time was 12 (9-14·9) months. There was no difference in achieving spermatogenesis between the two groups (64·3% vs 7·5%,P = 0·204), and even the median time for spermatogenesis was similar (15months vs 12months,P = 0·248). Both groups had nonsignificant median plasma AMH at spermatogenesis, [6·6 ng/ml (3·3-9·76) vs4·41 ng/ml (2·3-6·47), P = 0·298]. Similarly, the median plasma Inhibin B at spermatogenesis between groups were comparable [152·4 pg/ml (101·7-198·0) vs49·1 pg/ml (128·7-237·3), P = 0·488]. CONCLUSIONS: A reasonable approach to induce fertility in male CHH is to initiate combination therapy using FSH, low-dose hCG targeting AMH <6·9 ng/ml, along with T to achieve normal range. Monitoring AMH could serve as a proxy indicator of spermatogenesis.