For infertility treatment of females: Clomiphene Citrate is indicated for the management of anovulation or oligo-ovulation in women seeking pregnancy, provided their partners have adequate sperm count and the patients have functional hypothalamic-pituitary-ovarian axis with sufficient endogenous estrogen levels. It is also used in cases of lactational amenorrhoea, psychogenic amenorrhoea, post-oral contraceptive amenorrhoea, and certain cases of secondary amenorrhoea of unknown cause.

For infertility treatment of males: Clomiphene Citrate is indicated in men with infertility associated with low sperm count and reduced sperm motility.

Clomiphene primarily exhibits anti-estrogenic activity along with some estrogenic effects. Although the exact mechanism of ovulation induction is not fully understood, it is believed to be related to its anti-estrogenic action. By competing with estrogen at hypothalamic receptor sites, it increases the release of gonadotropins, including follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This leads to ovarian follicle development, a pre-ovulatory LH surge, ovulation, and formation of the corpus luteum. Its effectiveness in male infertility is also associated with increased secretion of FSH and LH.

For females: 50 mg daily for 5 days, starting any day from second to fifth day of the menstrual cycle if bleeding occurs or at any time if the patient had no recent uterine bleeding. A smaller dose or shorter duration may be necessary for individual unusually sensitive to clomiphene, such as women with polycystic ovary syndrome. If ovulation does not occur, the dose is increased to 75 mg to 100 mg daily for five days (the next course beginning as early as thirty days after the previous course). In general, three courses of therapy are adequate to assess whether ovulation is obtainable. If ovulation has not occurred, the diagnosis should be re-evaluated. If ovulation without conception occurs, this cycle is repeated until conception or for 3 or 4 cycles. If pregnancy has not occurred after a total of about 6 cycles, further clomiphene therapy is not recommended.

For males: 25 mg once daily up to 90 days. A break of 5 days after every 25 days is recommended.

Patients undergoing haemodialysis: Haemodialysis shortens serum half-life by 25–30%. In patients undergoing regular haemodialysis, a loading dose of 250 mg–1 g administered prior to dialysis.

Elderly: As adults.

Time to peak effect: Ovulation usually occurs 4 to 10 days (average 7 days) after the last day of treatment, this period of time may vary by patient and by cycle. In rare cases, ovulation may occur as late as 14 days after the last day of the treatment.

No drug interactions have been reported with the use of Clomiphene Citrate.

Pregnancy, hepatic impairment, and abnormal vaginal bleeding (such as due to uterine tumors or ovarian cysts).

At recommended doses, adverse effects are generally uncommon. The frequency and severity of side effects depend on the dose and duration of therapy and are usually reversible after discontinuation. Reported effects include visual disturbances, ovarian hyperstimulation, hot flushes, abdominal discomfort, occasional nausea and vomiting, depression, insomnia, breast tenderness, headache, intermenstrual spotting, menorrhagia, endometriosis, convulsions, weight gain, skin rash, dizziness, and hair loss. Higher doses (above 100 mg daily for five days) are associated with increased risk of side effects, and such patients should be closely monitored. Rare cases of ovarian cancer have been reported with fertility drugs; however, a direct causal relationship has not been established, as infertility itself is a risk factor.

Clomiphene Citrate is not recommended during pregnancy. It may reduce milk production if used during lactation; therefore, it should be avoided while breastfeeding.

Clomiphene Citrate should be used only under proper medical supervision after careful patient selection. A complete pelvic examination is required before initiating therapy and should be repeated before each treatment cycle to exclude pregnancy, ovarian enlargement, or cyst formation. The likelihood of multiple pregnancies increases if conception occurs during treatment.

Drugs for Infertility

Store below 30°C, protected from light and moisture. Keep out of the reach of children.