Elsevier

Urology

Volume 142, August 2020, Pages 119-124
Urology

Infertility
Baseline Gonadotropin Levels and Testosterone Response in Hypogonadal Men Treated With Clomiphene Citrate

https://doi.org/10.1016/j.urology.2020.04.074Get rights and content

Abstract

OBJECTIVE

To investigate the role of baseline gonadotropins in predicting the biochemical response to clomiphene citrate (CC) treatment.

METHODS

We conducted a retrospective review of data from hypogonadal men treated with CC in 2 high-volume fertility centers between 2013 and 2018. Patient age, body mass index, and baseline hormones (follicle stimulating hormone [FSH], luteinizing hormone [LH], and total testosterone [TT]) were obtained. Response to treatment was measured as changes in TT levels within 6 months of initiating CC treatment. Linear regression models adjusted for age, body mass index, and time on CC therapy were fitted to assess the associations between baseline LH and FSH levels with treatment response.

RESULTS

A total of 332 men with mean ± standard deviation age of 36.2 ± 8.2 years were included. Median time to initial follow-up was 6 weeks (25th-75th interquartile range [IQR]: 4-9 weeks). TT levels increased significantly on CC treatment (mean change: 329.2 ng/dL, 95% CI: 307.4-351.0) with 73% of men having at least 200 ng/dL increase over baseline TT levels. In univariable linear regression models, only age was significantly associated with TT response. Neither the baseline LH nor FSH significantly predicted TT response in linear regression models.

CONCLUSION

CC treatment results in significant increases in testosterone levels in most men. Baseline gonadotropins are not strong predictors for treatment response to CC. Adequate biochemical response with CC trial can be expected in most patients with normal or slightly elevated baseline gonadotropin levels.

Section snippets

Study Population

A retrospective review of data from all hypogonadal men treated with CC in 2 high-volume centers was performed from 2013 to 2018. Patient age, body mass index (BMI), and baseline hormones (follicle-stimulating hormone [FSH], luteinizing hormone [LH], estradiol [E], and total testosterone [TT]) were obtained. All hormone levels were based on early morning blood draws. Patients were excluded if they (1) were diagnosed with known genetic causes of primary hypogonadism (eg, Klinefelter syndrome);

RESULTS

A total of 332 men met the inclusion criteria with 66% also having a male infertility complaint. Mean ± SD age was 36.2 ± 8.2 years. Median FSH and LH levels at baseline were 4.3 mIU/mL (IQR: 2.7-7.3) and 4.2 mIU/mL (IQR: 2.8-6.2), respectively. Median baseline TT before treatment was 249.5 ng/dL (200.5-298.0). Baseline variables were not significantly different between the 2 centers except for patient age (38.2 ± 9.9 vs 35.4 ± 7.3 years, P = .005); ADAM scores were only available from one

DISCUSSION

This study confirms that CC is an effective treatment for increasing testosterone concentration in hypogonadal men and provides an inexpensive orally available alternative to exogenous testosterone and other injectable regimens. Seventy-three percent of men achieved at least 200 ng/dL increase in TT compared to their baseline levels. However, neither baseline LH nor FSH levels were strong predictors for biochemical response to CC treatment and we were not able to find an LH or FSH threshold

CONCLUSION

Treatment with CC results in a significant increase in testosterone levels in most men. However, pretreatment LH and FSH serum concentrations are not strong predictors of biochemical treatment response to CC. We were not able to find an LH or FSH threshold that provides a meaningful distinction between those who will or will not have a biochemical response to CC. Thus, adequate biochemical response with CC trial can be expected in most patients with normal or slightly elevated baseline

References (24)

Financial Disclosure: The authors declare that they have no relevant financial interests.

Statement: The abstract of this work is presented at the 20th annual Fall meeting of the Sexual Medicine Society of North America (SMSNA), October 24-27, 2019, in Nashville, TN, USA.

Conflict of Interest: None of the authors declare any conflicts of interests related to this work.

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