Serophene: Clinically Proven Ovulation Induction Therapy
Serophene
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Synonyms | |||
Serophene (clomiphene citrate) is a first-line oral fertility medication specifically designed to stimulate ovulation in women experiencing anovulatory disorders. As a selective estrogen receptor modulator (SERM), it works by blocking estrogen receptors in the hypothalamus, prompting increased secretion of gonadotropin-releasing hormone (GnRH). This cascade stimulates the pituitary gland to release follicle-stimulating hormone (FSH) and luteinizing hormone (LH), which are critical for follicular development and subsequent ovulation. Its established efficacy, favorable safety profile, and oral administration make it a cornerstone of infertility treatment protocols worldwide, offering a targeted approach to address one of the most common causes of female infertility.
Features
- Active ingredient: Clomiphene Citrate 50 mg
- Pharmaceutical class: Selective Estrogen Receptor Modulator (SERM)
- Administration: Oral tablet
- Standard packaging: 10-tablet blister packs
- Bioavailability: Approximately 85-90% following oral administration
- Half-life: 5-7 days
- Metabolism: Hepatic, via CYP2D6 and CYP3A4 isoenzymes
- Excretion: Primarily fecal (approximately 42-48%), with urinary excretion accounting for roughly 8%
Benefits
- Effectively induces ovulation in approximately 80% of appropriately selected anovulatory women
- Non-invasive oral administration eliminates the need for frequent injections
- Cost-effective first-line therapy compared to injectable gonadotropins
- Enables precise cycle monitoring and timing of intercourse or intrauterine insemination (IUI)
- Well-established safety profile with decades of clinical use and research
- Facilitates follicular development, increasing the probability of successful conception
Common use
Serophene is primarily indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Its use is most appropriate for patients with demonstrated hypothalamic-pituitary-ovarian axis competence, such as those with polycystic ovary syndrome (PCOS), normogonadotropic anovulation, or unexplained infertility. Clinicians often prescribe it as a first-line intervention before progressing to more complex assisted reproductive technologies (ART). Treatment is typically initiated after exclusion of other infertility factors, including male factor infertility, tubal occlusion, and uterine abnormalities. It is crucial to note that Serophene is not effective in cases of primary ovarian insufficiency or premature ovarian failure, where the ovarian follicular pool is depleted.
Dosage and direction
The recommended initial dosage of Serophene is 50 mg (one tablet) daily for five days, beginning on the fifth day of the menstrual cycle (with day 1 being the first day of menstrual bleeding). If ovulation does not occur at this dosage, the dose may be increased to 100 mg daily for five days in the subsequent cycle. Dosing beyond 100 mg daily is not recommended due to diminished efficacy and increased risk of adverse effects. Treatment should not exceed three to six cycles, as prolonged use may be associated with reduced efficacy and potential ovarian hyperstimulation. Patients are advised to undergo baseline transvaginal ultrasonography before initiating treatment and monitoring follicular development via ultrasound and/or serum estradiol levels during treatment cycles. Timing of intercourse or insemination is typically recommended 5-10 days after the last dose, based on follicular monitoring results.
Precautions
Prior to initiating Serophene therapy, a complete fertility evaluation must be conducted, including assessment of ovarian reserve, tubal patency, and semen analysis. Patients should be counseled on the increased risk of multiple gestation (approximately 5-10%, predominantly twins) and ovarian hyperstimulation syndrome (OHSS). Baseline liver function tests are recommended, as hepatic impairment may affect drug metabolism. Visual symptoms such as blurring, scotomas, or photophobia warrant immediate discontinuation and ophthalmologic evaluation. Endometrial thickness should be monitored, as clomiphene may have anti-estrogenic effects on the endometrium in some patients. Thyroid function should be evaluated and normalized before treatment, as thyroid disorders can affect ovulation. Patients with polycystic ovary syndrome should be screened for insulin resistance and metabolic abnormalities.
Contraindications
Serophene is contraindicated in patients with known hypersensitivity to clomiphene citrate or any component of the formulation. It must not be used during pregnancy, as it may cause fetal harm. Other contraindications include liver disease or dysfunction, abnormal uterine bleeding of undetermined origin, ovarian cysts (not associated with polycystic ovary syndrome), and uncontrolled thyroid or adrenal dysfunction. It is not indicated for use in patients with primary ovarian failure or premature ovarian insufficiency. The medication should not be administered to patients with organic intracranial lesions such as pituitary tumors.
Possible side effects
The most common adverse reactions (>10%) include vasomotor flushes (similar to hot flashes), abdominal discomfort, bloating, and ovarian enlargement. Less frequent side effects (1-10%) comprise nausea/vomiting, breast tenderness, visual disturbances (blurring, photophobia, diplopia), headache, and abnormal uterine bleeding. Rare but serious adverse events (<1%) include ovarian hyperstimulation syndrome (OHSS), which may present with rapid weight gain, abdominal pain, nausea, vomiting, and oliguria. Cases of ovarian torsion and ectopic pregnancy have been reported. Visual symptoms typically resolve upon discontinuation but warrant thorough ophthalmologic evaluation. Some patients may experience mood swings or emotional lability during treatment.
Drug interaction
Serophene may interact with medications that affect estrogen levels or metabolism. Concomitant use with gonadotropins may increase the risk of ovarian hyperstimulation syndrome. Drugs that induce CYP3A4 (e.g., rifampin, carbamazepine, St. John’s Wort) may decrease clomiphene concentrations, potentially reducing efficacy. Conversely, CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase serum levels. Tamoxifen and other SERMs may have additive effects. Estrogen-containing therapies may interfere with the mechanism of action of clomiphene. Dopamine agonists such as bromocriptine may be used concomitantly in hyperprolactinemic patients. Always inform your healthcare provider of all medications, including over-the-counter drugs and supplements.
Missed dose
If a dose of Serophene is missed, the patient should take it as soon as remembered unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Patients should not double the dose to make up for a missed tablet. Given the fixed five-day dosing regimen at the beginning of the cycle, missed doses may compromise treatment efficacy for that cycle. Patients should contact their healthcare provider for guidance if they miss one or more doses, as cycle monitoring may need adjustment.
Overdose
There is limited experience with Serophene overdose. Symptoms may be an exaggeration of known adverse effects, including severe nausea/vomiting, vasomotor symptoms, visual disturbances, and ovarian enlargement. There is no specific antidote for clomiphene citrate overdose. Treatment should be supportive and symptomatic. Gastric lavage may be considered if ingestion was recent. Due to the drug’s long half-life, effects may persist for several weeks. Patients should receive appropriate monitoring, particularly for signs of ovarian hyperstimulation syndrome. Dialysis is not likely to be effective due to high protein binding.
Storage
Store Serophene tablets at controlled room temperature (20-25°C or 68-77°F), with excursions permitted between 15-30°C (59-86°F). Keep in the original container, tightly closed, and protect from light and moisture. Do not store in bathroom cabinets where humidity levels may fluctuate. Keep out of reach of children and pets. Do not use tablets that appear discolored or show signs of deterioration. Properly dispose of any unused medication after treatment completion, following local regulations for medication disposal.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Serophene is a prescription medication that should be used only under the supervision of a qualified healthcare provider specializing in reproductive medicine. Individual response to treatment may vary, and not all patients will achieve ovulation or pregnancy. The benefits and risks should be carefully discussed with your physician before initiating treatment. This information does not cover all possible uses, directions, precautions, or adverse effects.
Reviews
Clinical studies and patient reports consistently demonstrate Serophene’s efficacy in inducing ovulation, with success rates ranging from 70-80% in appropriately selected patients. Among ovulatory cycles, pregnancy rates average 15-20% per cycle, accumulating to approximately 45-50% over three to six treatment cycles. Many reproductive endocrinologists regard it as the gold standard first-line treatment for anovulatory infertility. Patients appreciate the oral administration and relatively low cost compared to injectable alternatives. Some reports note concerns about side effects, particularly vasomotor symptoms and the emotional impact of treatment cycles. Overall, it remains a foundational therapy in reproductive medicine with decades of documented success.