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PubMed1985

Testicular germ cell tumors after clomiphene therapy for subfertility.

The stimulatory effect of low doses of clomiphene citrate on the human male gonad is accepted widely. We used 25 mg. clomiphene daily for 3 weeks, with 1 week of rest, for 6 to 12 months in 650 oligospermic men without increased serum levels of follicle-stimulating hormone (less than 20 IU/l.). Unilateral testicular neoplasm developed in 2 subjects. Although a definite cause-and-effect relationship between treatment and tumor development cannot be assigned the possible risk of tumor development in men undergoing long-term clomiphene treatment is suggested. Since clomiphene administration or gonadotropin treatment might enhance tumor development in men, patients at risk undergoing such therapy should be examined frequently and when a testicle enlarges a malignant tumor must be ruled out.

Adult↗
PubMed1981

High-performance liquid chromatographic determination of clomiphene using post-column on-line photolysis and fluorescence detection.

A method has been developed for the extraction and quantitation of the ovulatory stimulant drug clomiphene from plasma. The cis- and trans-isomers were separated by normal-phase chromatography using chloroform-methanol as the mobile phase. After eluting from the column, the clomiphene was passed through a PTFE photolysis coil irradiated by a powerful UV lamp, resulting in conversion of the isomers to highly fluorescent species. The derivatised material was then detected using a fluorescence spectrometer. Use of this method enables a substantial improvement of sensitivity over UV detection and has permitted the measurement of plasma clomiphene levels in patients receiving clomiphene therapy.

Automation↗
PubMed1985

Basal prolactin and the behaviour of the gonadotrophins, testosterone, androstenedione, estradiol, and the sex-hormone-binding globulin during stimulation with clomiphene in subjects with spermatogenic disorders.

To clarify the significance of clomiphene test in spermatogenic disorders, it was performed on three groups of subjects: 10 with normozoospermia, 29 with oligozoospermia, and 11 with azoospermia. Two basal blood samples were drawn five days apart; prolactin, FSH, LH, estradiol, testosterone, androstenedione and sex-hormone-binding globulin were determined. 100 mg of clomiphene per day were administered for eleven consecutive days; another sample was drawn on the eleventh day and all the basal parameters, except prolactin, were determined. It may be concluded from the results: a) All the parameters studied increased significantly after clomiphene; and b) Testosterone levels obtained after clomiphene, as well as the increases in this hormone during the test and the ratio delta T/delta LH, were significantly lower in the oligozoospermic group. This finding suggests a decrease in the testicular androgenic function of this group.

Adult↗
PubMed2004

Pregnancy outcomes with increased clomiphene citrate dose.

Our objective was to evaluate whether ovulation induction with an increased clomiphene citrate dose of 150-250 mg/day for 5 days adversely affected pregnancy outcome. A retrospective chart review of 1910 medical records yielded 119 pregnancies with sufficient information regarding domiphene dose and pregnancy outcome. Of the 84 pregnancies that followed clomiphene doses of 50-100 mg/day, 32.1% ended in spontaneous abortion, 10.7% in ectopic gestation, 1.2% with congenital malformations, 2.4% in stillbirth and 53.6% in normal gestation. Of the 35 pregnancies that followed clomiphene doses of 150-250 mg/day, 34.3% ended in spontaneous abortion, 5.7% in ectopic gestation, 2.9% with congenital malformations, 2.9% in stillbirth and 54.3% in normal gestation. These differences were not statistically significant. These data suggest that a clomiphene dose of 150-250 mg/day does not appear to increase adverse pregnancy outcomes.

Abortion, Spontaneous↗
PubMed1997

Clomiphene citrate as a possible cause of a psychotic reaction during infertility treatment.

Secondary side-effects often occur in women undergoing hormonal stimulation treatment with clomiphene citrate. In general 10.4% of women experience hot flushing, 5.5% have complaints caused by enlargement of the ovaries and 3.5% experience central nervous symptoms (nervousness, sleeplessness, headaches, visual disturbances, vertigo). During ovarian stimulation with clomiphene citrate for in-vitro fertilization, a 32 year old patient developed psychotic symptoms, commencing 3 days after initiation of treatment. Hospitalization in the psychiatric ward became necessary when severe formal and rational thought disturbances arose together with perceptory and sensory delusions. Under neuroleptic treatment the symptoms improved. Nevertheless, follow-up psychiatric care on an outpatient basis was deemed necessary. The infertility treatment was continued with human menopausal gonadotrophin stimulation. Psychiatric instability occurred neither at this point nor during the 2 year follow-up observation period. Both an exogenous psychosis (ICD F23.9) as well as the exacerbation of an endogenous psychosis (ICD F29) may be considered for the differential diagnosis. The stimulation with clomiphene citrate in connection with the physical and psychic stress of the infertility therapy can be regarded as the trigger factor. For patients with evidence of psychiatric illness in their case history, ovulation-inducing substances such as clomiphene citrate should be implemented with particular care.

Adult↗
PubMed2002

A randomized double-blind comparison of perifollicular vascularity and endometrial receptivity in ovulatory women taking clomiphene citrate at two different times.

BACKGROUND: It is still controversial whether the day of clomiphene citrate initiation has any impact on the pregnancy rate. This study aimed to compare the perifollicular vascularity and endometrial receptivity of ovulatory women who started clomiphene citrate on day 2 and day 5. METHODS: Thirty-five women with regular ovulatory cycles were first monitored in a natural cycle and then randomized by computer-generated random numbers put in sealed opaque envelopes to receive 50 mg clomiphene citrate on days 2-6 or on days 5-9. The hormonal profile, the number of dominant follicles, the grading of perifollicular vascularity, endometrial thickness and Doppler flow indices of uterine/subendometrial arteries were compared between both groups. RESULTS: All the above parameters were similar for both groups on the day of the LH surge and 7 days after the LH surge. CONCLUSIONS: There were no differences in oocyte quality graded by the perifollicular vascularity and the endometrial receptivity assessed by endometrial thickness and Doppler flow indices of uterine and subendometrial vessels when clomiphene citrate was started in regularly ovulatory women on day 2 or on day 5.

Adult↗
PubMed1988

Ovarian stimulation for in-vitro fertilization: clomiphene and HMG.

Details of the problems and successes obtained after various forms of hormonal stimulation in an IVF programme are presented. The endocrine conditions normally existing in the natural menstrual cycle are discussed first, followed by analyses of the types of responses to clomiphene, clomiphene and HMG, HMG alone and LHRH agonists. Clomiphene produces fewer embryos than other treatments but gives a good control of follicle growth and ovulation. Clomiphene and HMG increases the number of available oocytes, and this raises the chance of pregnancy, but there is a greater heterogeneity in the follicular population. HMG alone is suitable for most conditions except for those with PCO syndrome and gives an average of six oocytes per treatment cycle. The problems associated with premature rises in levels of LH are overcome by using LHRH agonists with HMG, and this results in satisfactory numbers of oocytes but requires endocrine support in the luteal phase. The need for luteal phase support after various therapies remains unclear, and a calculation of the ratios between various steroids may help to clarify the need for it.

Clomiphene↗
PubMed2004

An economic evaluation of laparoscopic ovarian diathermy versus gonadotrophin therapy for women with clomiphene citrate resistant polycystic ovary syndrome.

BACKGROUND: Laparoscopic ovarian diathermy and gonadotrophin ovulation induction for women with clomiphene citrate resistant polycystic ovary syndrome have been shown to result in similar pregnancy rates, but their relative cost-effectiveness has not been evaluated. METHODS: A cost-minimization study was undertaken alongside a randomized controlled trial in women with anovulatory infertility secondary to clomiphene resistant polycystic ovary syndrome. Inclusion criteria were age less than 39 years, body mass index less than 35 kg/m(2), failure to ovulate with 150 mg of clomiphene citrate for 5 days in the early follicular phase, more than 12 months of infertility and no other causes of infertility. Laparoscopic ovarian diathermy was compared with three cycles of urinary or recombinant gonadotrophins. Direct and indirect costs were based on the results of a randomized trial. RESULTS: The cost of a live birth was one third lower in the group that underwent laparoscopic ovarian diathermy compared to those women who received gonadotrophins (19 640 New Zealand dollars and 29 836 New Zealand dollars, respectively). CONCLUSIONS: This economic evaluation shows that treating women with clomiphene-resistant polycystic ovarian syndrome with laparoscopic ovarian diathermy results in a significant reduction in both direct and indirect costs.

Adult↗
PubMed1988

Improved treatment for anovulation in polycystic ovarian disease utilizing the effect of progesterone on the inappropriate gonadotrophin release and clomiphene response.

The treatment of anovulatory, clomiphene-resistant patients with polycystic ovarian disease (PCOD) is difficult. Ten such women were given progesterone, 50 mg/day i.m. for 5 days to achieve luteal phase concentrations. Immediately following progesterone treatment, plasma concentrations of FSH were reduced in all patients (P = 0.001) and seven of the 10 had reduced plasma LH concentrations. Following the withdrawal bleeding these seven all became responsive to clomiphene as shown by ovulation, and three conceived after a single progesterone/clomiphene cycle. LH pulsatility, studied in five women over 4 h, before and immediately following progesterone treatment, showed a slowing of the pulse frequency (62 +/- 26 min to 105 +/- 51 min, P less than 0.05) and an increase in pulse amplitude (6 +/- 1.9 IU/l to 16.7 +/- 20 IU/l). The LH and FSH response to GnRH was blunted by progesterone. It would thus appear that progesterone modulates LH pulsatility and reduces pituitary sensitivity to GnRH, reducing LH levels and possibly inducing more FSH synthesis and storage, similar to its action in the normal ovulatory cycle. These changes provide a more favourable environment for ovulation induction by clomiphene and we suggest that short-term progesterone treatment may be utilized to improve the efficiency and results of clomiphene treatment in PCOD.

Anovulation↗
PubMed1990

Anti-oestrogenic effect of clomiphene citrate in oestrogen-treated, hypogonadal women.

The effect of clomiphene on the pituitary response to exogenous LHRH was investigated in five hypogonadal women during long-term treatment with varying doses of oestrogen. In three of them, basal LH levels were low (less than 10 mIU/ml) and increased significantly after 8 days of treatment with clomiphene (100 mg/day). Clomiphene augmented the LH and FSH response to LHRH (an acute i.v. injection of 100 micrograms) and changed the pattern of response into that seen in the absence of the influence of ovarian steroids. We conclude that clomiphene exerts anti-oestrogenic effects on basal and LHRH-stimulated release of gonadotrophins in hypogonadal women during long-term treatment with oestrogen.

Adult↗
PubMed2006

Basal ovarian cysts and clomiphene citrate ovulation induction cycles.

OBJECTIVE: To evaluate the effect of simple basal ovarian cysts in patients undergoing infertility treatment with clomiphene citrate. To evaluate the effect of clomiphene citrate on pretreatment simple ovarian cysts. METHODS: Prospective cohort trial of 84 infertility patients undergoing ovulation induction with clomiphene citrate. Patients with basal ovarian cysts of 10 mm or greater (n = 42) were compared with patients without ovarian cysts (n = 42). The main outcome measure was ovulation determined by menstrual cycle day 21 progesterone level. Each patients with an ovarian cyst was also evaluated for persistence or resolution of the cyst in association with ovulation and cyst size. Pretreatment and posttreatment transvaginal ultrasound examinations were performed on all patients. RESULTS: Demographic data were similar among the groups. The mean ovarian cyst size was 17.4 +/- 5.8 mm. Patients in the ovarian cyst group were significantly less likely to ovulate (80.9% versus 97.6%, P < .05), but did not differ in pregnancy rate compared with patients without baseline ovarian cysts (4.8% versus 11.9%, P = .43). Persistent ovarian cysts occurred in 36.7% of the patients. The initial size of the cyst did not predict cyst persistence. CONCLUSION: According to these data, basal ovarian cysts significantly reduce ovulatory events in patients treated with clomiphene citrate. LEVEL OF EVIDENCE: II-2.

Adult↗
PubMed2004

Comparison of the antiproliferative properties of antiestrogenic drugs (nafoxidine and clomiphene) on glioma cells in vitro.

The antitumoral activity of nonsteroidal antiestrogens on C6 and low passage of human glioma cells was investigated. Tamoxifen and its metabolite, 4-hydroxytamoxifen, did not influence viability of the human cells, but tamoxifen had a limited antiproliferative effect on C6 cells (IC50: 49 micromol/l). The derivatives of tamoxifen, nafoxidine and clomiphene, caused reduction of living cell number in a dose-dependent manner. These two drugs showed differences in their potency following 24-hour incubation in a humidified atmosphere with 37 degrees C and 5% CO2. Obtained from a tetrazolium-formazan growth rate assay, IC50 of nafoxidine for C6 cells was calculated as 44 micromol/l and for the human cells as 16.5 micromol/l. The calculated IC50 dose of clomiphene for C6 is 16 micromol/l and for the human cells 13 micromol/l. Compared to the other drugs we used, it is clear that clomiphene is the most efficient inhibitor of C6 and the human glioma cells. These preliminary results suggest that nafoxidine and clomiphene possess antiproliferative effect on two different sources of glioma cells and therefore, instead of tamoxifen, multiple activities of these drugs may enable their use in combination therapy of glioblastoma malignancies.

Animals↗
PubMed1979

The effect of clomiphene on uncastrated and castrated male transsexuals.

Clomiphene was administered at a daily dose of 100 mg for 5 consecutive days to two groups of male subjects. There were three uncastrated male transsexuals (Group A) and nine castrated male transsexuals (Group B). In the uncastrated subjects Clomiphene enhanced the secretion of follicle-stimulating hormone (FSH), luteinizing hormone (LH) and testosterone (T) starting from day 3 of treatment. The magnitude of the increment ranged from 150%--250% over the mean basal plasma level for LH, 113%--262% for FSH and 12%--68% for T. In contrast, Clomiphene suppressed both FSH and LH in the castrated subjects. Equal suppression of both the gonadotrophins were observed. The levels of FSH and LH in plasma on day 3 were suppressed to 66.4% and 66.2% of their respective mean basal levels. Two days after the termination of treatment, suppressions were maintained. These results suggest that Clomiphene acts as an anti-oestrogen in uncastrated male transsexuals and in castrated male transsexuals who have subphysiological levels of oestradiol it acts as a weak oestrogen.

Adult↗
PubMed1982

Pubertal maturation of the lh stimulatory response to clomiphene citrate in congenital virilizing adrenal hyperplasia.

To determine the LH release response to clomiphene citrate in children with virilizing congenital adrenal hyperplasia (CAH), we examined six patients with glucocorticoid-treated virilizing CAH, five girls and one boy, chonological age (CA) 4 years 2 months-15 years 9 months and bone age (BA) range 8-18 years. All the patients but one, were treated with nocturnal dexamethasone. Their ages at the onset of treatment ranged from 2 years 6 months to 13 years 8 months. An additional boy (CA = 4 years 3 months and BA = 7-8 years) was studied 10 days after removal of a virilizing adrenal adenoma. Clomiphene citrate (3mg/kg/day) was administered orally in two doses/day for 8 days. Venous blood was collected on days 0, 4, 6 and 8. Two patients were also studied in consecutive years. In three patients no increase was noted over the basal levels of LH, but in the others LH rose during clomiphene administration. In two patients studied in consecutive years, there was detectable shift of LH release pattern. The basal LH levels and the sum of responses (day 4, 6 and 8) to clomiphene citrate and particularly their decimal logarithms were statistically significantly correlated with their respective BA. These results confirm that previous prolonged exposure to elevated concentrations of adrenal sex steroids, in children with treated virilizing CAH, may induce precocious maturation of the hypothalamic pubertal mechanism of LH secretion. This maturation was closely correlated with the degree of skeletal maturation.

Adrenal Hyperplasia, Congenital↗
PubMed1982

Clomiphene citrate does not modify the exaggerated thyrotrophin response to thyrotrophin-releasing hormone occurring in primary testicular failure.

Patients with primary testicular failure have increased basal TSH levels and an exaggerated TSH response to TRH in the presence of normal circulating levels of thyroid hormones. In order to evaluate it this TSH profile is an oestrogen-related phenomenon, sixteen patients with primary testicular failure were challenged with 200 micrograms TRH prior to and after the administration of clomiphene citrate. The latter was given in a dose of 100 mg/day for 4 weeks to ten patients; 200 mg/day for 4 weeks to three patients and 100 mg/day for 2 months to the final three patients. The patients demonstrated increased mean basal TSH levels with an exaggerated TSH response to TRH. Following the administration of clomiphene citrate, there were no changes in T4, T3 sephadex or total T3 levels and in basal or stimulated TSH levels. Clomiphene did produce an increase in oestradiol, testosterone, basal gonadotrophins and LH response to LHRH. Since the oestrogen antagonist, clomiphene citrate, had no effect on TSH secretion, it is unlikely that the exaggerated TSH response to TRH is mediated by oestrogens.

Adult↗
PubMed1988

Blockage of the positive feedback effect of oestradiol during prolonged administration of clomiphene citrate to normal women.

The effect of clomiphene citrate on the occurrence and timing of the endogenous LH surge in superovulated cycles is unclear. To study further this event, five normally ovulating women were treated with clomiphene citrate 100 mg per day in two different cycles, that is, for 5 days in one cycle (days 2 to 6, CC-5) and for 15 days in another cycle (days 2 to 16, CC-15). During the CC-5 cycle, the normal pattern of LH levels seen in spontaneous cycles was observed with an endogenous LH surge in all women followed by ovulation and normal luteal function. In contrast, during the CC-15 cycle, a continuous and progressive increase of basal LH levels was seen with no surge, resulting in follicular luteinization but no ovulation. The results suggest that in normal women treated with clomiphene the occurrence of an endogenous LH surge is dependent on a significant decrease in the circulatory concentration of clomiphene at mid-cycle.

Clomiphene↗
PubMed1979

Oestrogen-gonadotrophin feedback abnormalities in hyperprolactinaemic amenorrhoea demonstrated by the response to clomiphene administration.

Clomiphene was administered to 16 patients with elevated serum prolactin levels in doses of 100, 200 and 300 mg/day for five days in succeeding months and total urinary oestrogens estimated on days 0, 5, 8, 12 and 15 following commencement of treatment. The responses were compared with six patients who were amenorrhoeic but had normal serum prolactin levels and absent positive feedback to oestrogen. The increased outputs of oestrogens were similar in the two groups. In the hyperprolactinaemic group 5 out of 16 subjects showed evidence of ovulation whilst the remainder showed a secondary failure of response. Six subjects who failed to ovulate were treated with clomiphene and human chorionic gonadotrophin (HCG) and ovulations were induced in 31 out of 34 treatment cycles but no pregnancies were achieved. The responses to clomiphene therapy in the hyperprolactinaemic subjects were compared to the assessment of positive feedback mechanisms by means of oestrogen provocation and oestrogen amplification tests and good correlation was obtained. Only those with evidence of positive feedback to these tests were likely to ovulate on clomiphene.

Amenorrhea↗
PubMed1992

A prospective, randomised, cross-over study comparing the effects of clomiphene citrate and cyclofenil on endometrial morphology in the luteal phase of normal, fertile women.

OBJECTIVE: To examine the effect of two anti-oestrogens, clomiphene citrate and cyclofenil, on endometrial morphology in the luteal phase. DESIGN: A prospective, randomised, cross-over study. SETTING: Jessop Hospital for Women, Sheffield, UK. SUBJECTS: 10 women who were previously fertile and regularly cycling. INTERVENTION: The administration of clomiphene citrate or cyclofenil in the treatment cycles. A LH timed endometrial biopsy was taken on day LH + 6. MAIN OUTCOME MEASURES: Histological dating and morphometric analysis of the endometrial sample. RESULTS: Only one out of 10 subjects had abnormal endometrium. There was no difference in the results between cycles treated with clomiphene citrate and cyclofenil. CONCLUSIONS: Clomiphene citrate or cyclofenil does not have a major adverse effect on endometrial morphology in the luteal phase of normal fertile subjects. The possible adverse effects of anti-oestrogens on endometrium may have been previously overestimated.

Adult↗