madman
Super Moderator
MP43-13 ENCLOMIPHENE IS ASSOCIATED WITH HIGHER PREGNANCY RATES WHEN COMPARED TO CLOMIPHENE IN INFERTILE MEN WITH LOW TESTOSTERONE (2023)
Jordan Kassab, Juan Torres-Anguiano*, John Lindsey, Houston, TX; Jabez Gondokusumo, Sabine Itani, Mohamad Jabin, Bryan, TX; Larry Lipshultz, Houston, TX
INTRODUCTION AND OBJECTIVE
Clomiphene citrate has been used for decades for female infertility; however, it has also been used off-label for many years to treat infertile males with low testosterone. Enclomiphene citrate is the trans isomer of clomiphene citrate and is another off-label medication for the same at-risk population but with no estrogenic agonism. The purpose of this study is to evaluate and compare the pregnancy outcomes of couples seeking fertility who have been treated with either clomiphene or enclomiphene as well as quantitating effects on serum hormones.
METHODS
We studied patients with low testosterone and infertility who had been prescribed either clomiphene or enclomiphene at a university hospital within the observation range of 01/01/2021 - 08/ 01/2022. Dosage information as well as baseline serum hormone levels (LH, FSH, testosterone, estradiol) were captured into a patient database. T-tests were calculated in SPSS to compare means across the clomiphene and enclomiphene patient populations; a two-sample Z-test was used to compare pregnancy outcomes.
RESULTS
110 patients taking clomiphene were compared to 114 patients taking enclomiphene, with the former demonstrating higher testosterone levels (886 ng/dL vs. 547 ng/dL), [t(222)=4.25, p=.000031]. Those taking enclomiphene had significantly higher levels of both LH (6.08 IU/L vs. 4.26 IU/L) and FSH (6.46 IU/L vs. 4.17 IU/L), [t(195)=2.36, p=.019 and t(195)=2.29, p=.023, respectively]. Estradiol also demonstrated a difference between the groups: the mean for clomiphene patients was 35.34 pg/mL, whereas the mean for enclomiphene patients was 29.85 pg/mL [(213)=2.00, p=.047]. Most importantly, enclomiphene patients demonstrated significantly higher rates of pregnancy compared to the clomiphene patients (52% vs. 34%, p=.046).
CONCLUSIONS
The empirical treatment of unexplained male infertility has for many years utilized clomiphene citrate in patients with concurrent low testosterone. This study evaluates the use of single trans-isomer enclomiphene and demonstrates its association with better pregnancy outcomes when compared to clomiphene. Future studies should focus on the use of enclomiphene in a blinded prospective manner to better define its efficacy.
Jordan Kassab, Juan Torres-Anguiano*, John Lindsey, Houston, TX; Jabez Gondokusumo, Sabine Itani, Mohamad Jabin, Bryan, TX; Larry Lipshultz, Houston, TX
INTRODUCTION AND OBJECTIVE
Clomiphene citrate has been used for decades for female infertility; however, it has also been used off-label for many years to treat infertile males with low testosterone. Enclomiphene citrate is the trans isomer of clomiphene citrate and is another off-label medication for the same at-risk population but with no estrogenic agonism. The purpose of this study is to evaluate and compare the pregnancy outcomes of couples seeking fertility who have been treated with either clomiphene or enclomiphene as well as quantitating effects on serum hormones.
METHODS
We studied patients with low testosterone and infertility who had been prescribed either clomiphene or enclomiphene at a university hospital within the observation range of 01/01/2021 - 08/ 01/2022. Dosage information as well as baseline serum hormone levels (LH, FSH, testosterone, estradiol) were captured into a patient database. T-tests were calculated in SPSS to compare means across the clomiphene and enclomiphene patient populations; a two-sample Z-test was used to compare pregnancy outcomes.
RESULTS
110 patients taking clomiphene were compared to 114 patients taking enclomiphene, with the former demonstrating higher testosterone levels (886 ng/dL vs. 547 ng/dL), [t(222)=4.25, p=.000031]. Those taking enclomiphene had significantly higher levels of both LH (6.08 IU/L vs. 4.26 IU/L) and FSH (6.46 IU/L vs. 4.17 IU/L), [t(195)=2.36, p=.019 and t(195)=2.29, p=.023, respectively]. Estradiol also demonstrated a difference between the groups: the mean for clomiphene patients was 35.34 pg/mL, whereas the mean for enclomiphene patients was 29.85 pg/mL [(213)=2.00, p=.047]. Most importantly, enclomiphene patients demonstrated significantly higher rates of pregnancy compared to the clomiphene patients (52% vs. 34%, p=.046).
CONCLUSIONS
The empirical treatment of unexplained male infertility has for many years utilized clomiphene citrate in patients with concurrent low testosterone. This study evaluates the use of single trans-isomer enclomiphene and demonstrates its association with better pregnancy outcomes when compared to clomiphene. Future studies should focus on the use of enclomiphene in a blinded prospective manner to better define its efficacy.
