Pregina Indications/Uses

Clomifene citrate is indicated for induction of ovulation in patients with persistent ovulatory dysfunction who desire pregnancy. The work-up and treatment of candidates for clomifene therapy should be supervised by physicians experienced in the management of gynecologic or endocrine disorders. Patients should be chosen for therapy with clomifene only after careful diagnostic evaluation. The work-up of the patient must begin with a careful and detailed historv of menstrual and reproductive function, and a complete physical examination. It should be followed by a selective and careful laboratory investigation based on historical and physical findings.
1. Exclusion of pregnancy: Treatment should be withheld until diagnosis of pregnancy has been ruled out.
2. Assessment of abnormal excessive bleeding: Patients with this condition should be evaluated prior to therapy. It is important to ensure that neoplastic lesions are not overlooked.
3. Exclusion of presence or history of liver dysfunction: Assess liver function prior to treatment.
4. Exclusion of presence of ovarian cyst: Do not use clomifene citrate in patients with ovarian enlargement except those with polycystic ovary syndrome (PCOS). Perform pelvic examination before the first and each subsequent treatment cycle.
5. Confirmed ovulatory dysfunction: Establish the diagnosis of ovulatory dysfunction by standard techniques such as basal body temperature curves, serial vaginal smears, cervical mucus, endometrial biopsy, and pregnanediol determination.
6. Exclusion of primary pituitary or ovarian failure: Successful therapy with clomifene requires intact pituitary and ovaries. Ovulatory dysfunction in the presence of abnormally high levels of pituitary gonadotropins indicates ovarian failure and does not respond to clomifene.
7. Assessment of estrogen levels: Adequate levels of endogenous estrogen provide a favorable prognosis for treatment with clomifene. Physiologic indicators of normal endogenous estrogen include vaginal smears, cervical mucus, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone. Reduced estrogen level, although less favorable, does not preclude successful therapy.
8. Exclusion of mechanical impediments to conception: Exclude or adequately treat mechanical impediments to conception (e.g., tubal obstruction) before taking clomifene.
9. Exclusion of medical impediments to pregnancy: Clomifene is not a substitute for appropriate therapy of other disturbances leading to ovulatory dysfunction (e.g., diabetes, diseases of the thyroid and adrenals). Specific treatment should be undertaken and subfertility therapy reconsidered only after the underlying disorder has been adequately treated.
10. Exclusion of male factor infertility: Determine the husband's fertility potential using semen analysis and other indicated examination. The efficacy of clomifene for male infertility has not been established. Testicular tumors and gynecomastia have been reported in men using clomifene citrate. However, the cause and effect relationship between reports of testicular tumors and the administration of clomifene is unknown.
Clomifene has also been used in conjunction with gonadotropins and in in vitro fertilization programmes.
Clomifene has also been used in the treatment of male fertility due to oligospermia to stimulate gonadotropin release and enhance spermatogenesis.