Fertomid (clomiphene citrate) is a first-line, orally administered selective estrogen receptor modulator (SERM) indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. It represents a cornerstone of fertility therapy, primarily by antagonizing estrogen receptors at the hypothalamus, which disrupts the negative feedback loop. This action prompts an increase in gonadotropin-releasing hormone (GnRH) secretion from the hypothalamus, subsequently stimulating the pituitary gland to release follicle-stimulating hormone (FSH) and luteinizing hormone (LH). The resultant rise in these gonadotropins initiates and sustains follicular recruitment, growth, and maturation, culminating in ovulation. Its non-invasive oral administration and well-established efficacy profile make it a primary therapeutic option before advancing to more complex assisted reproductive technologies (ART).

Features

• Active Pharmaceutical Ingredient (API): Clomiphene Citrate.
• Therapeutic Class: Selective Estrogen Receptor Modulator (SERM), Ovulation Inducer.
• Standard Available Strengths: 25 mg and 50 mg tablets.
• Administration Route: Oral.
• Mechanism of Action: Functions as a partial estrogen agonist/antagonist by competitively binding to estrogen receptors, predominantly at the level of the hypothalamus.
• Bioavailability: Well-absorbed orally, with significant enterophepatic circulation.
• Half-life: The zuclomiphene isomer exhibits a prolonged half-life of up to two weeks, accumulating over successive treatment cycles.

Benefits

• Induces Controlled Ovarian Stimulation: Effectively promotes the development and release of a mature ovum, addressing the primary barrier to conception in anovulatory women.
• High Rate of Monofollicular Development: When administered at the correct dosage, it encourages the growth of a single dominant follicle in a significant proportion of cycles, thereby minimizing the risk of multifetal gestation compared to injectable gonadotropins.
• Non-Invasive Treatment Option: As an oral medication, it offers a convenient and less stressful initiation to fertility treatment compared to subcutaneous or intramuscular injections.
• Cost-Effective First-Line Therapy: Provides a highly accessible and economically viable initial approach for managing ovulatory disorders.
• Restores Endocrine Feedback Loops: Works with the body’s own hormonal pathways to stimulate a physiologic ovulatory process rather than replacing hormones exogenously.
• Facilitates Timed Intercourse or IUI: Successfully triggers ovulation, allowing for precise timing of intercourse or intrauterine insemination (IUI) to maximize the probability of conception.

Common use

Fertomid is principally prescribed for the induction of ovulation in women with ovulatory dysfunction who wish to achieve pregnancy. Its use is most successful in patients with intact hypothalamic-pituitary-ovarian (HPO) axis function, such as those diagnosed with World Health Organization (WHO) Group II anovulation, which includes conditions like Polycystic Ovary Syndrome (PCOS). It is also used off-label for the empirical treatment of unexplained infertility and to test ovarian reserve. Furthermore, it may be utilized in controlled ovarian hyperstimulation protocols for in vitro fertilization (IVF), though gonadotropins are more common for this advanced application. Treatment is always initiated and meticulously monitored under the supervision of a fertility specialist.

Dosage and direction

Treatment must be individualized based on patient response, which is evaluated via transvaginal ultrasonography and serum progesterone levels.

• Initial Dose: The recommended starting dose is 50 mg (one tablet) daily for 5 days, beginning on day 3, 4, or 5 of the menstrual cycle (with day 1 being the first day of spontaneous or progestin-induced menstrual bleeding).
• Dose Titration: If ovulation is confirmed but pregnancy does not occur, the cycle may be repeated. If ovulation does not occur at the 50 mg dose, the dose may be increased to 100 mg daily for 5 days in the next cycle. Incremental increases to a maximum of 150 mg daily for 5 days may be attempted in subsequent cycles if needed.
• Duration of Therapy: Treatment should not exceed 3 to 6 cycles due to a potential increased risk of ovarian cancer with prolonged use and a diminishing cumulative pregnancy rate thereafter. If ovulation occurs but pregnancy is not achieved after 3-6 ovulatory cycles, further diagnosis and alternative treatment should be considered.
• Timing of Intercourse: Patients are advised to have intercourse daily beginning 5 to 8 days after the last dose of Fertomid and continuing until ovulation is confirmed, typically around days 14-18 of the cycle.

Precautions

• Medical Supervision: Therapy mandates strict supervision by a physician experienced in fertility treatment. Monitoring via ultrasound and hormonal assays is essential to assess follicular growth, prevent hyperstimulation, and determine the optimal time for ovulation.
• Ovarian Hyperstimulation Syndrome (OHSS): Although less common than with gonadotropin therapy, OHSS is a serious medical complication that can occur. Patients should be counseled to report severe pelvic pain, abdominal distention, nausea, vomiting, or sudden weight gain immediately.
• Visual Disturbances: Patients should be warned about the potential for blurred vision, scotomas, or photophobia, which usually resolve upon discontinuation but necessitate immediate cessation of the drug and an ophthalmologic examination.
• Ovarian Cysts: May cause functional ovarian cysts, which typically resolve spontaneously. A baseline ultrasound is recommended before initiating a new treatment cycle.
• Multiple Pregnancy: The incidence of multiple gestation (primarily twins) is increased to approximately 5-10% compared to 1% in the general population. The risk of high-order multiples (triplets or more) is low but present.
• Long-Term Use: Avoid use beyond the recommended number of cycles due to a potential association with borderline ovarian tumors.

Contraindications

Fertomid is strictly contraindicated in the following patient populations:

• Pregnancy: It is contraindicated during pregnancy (Pregnancy Category X). A pregnancy test must rule out gestation before each treatment cycle.
• Liver Disease: Patients with pre-existing liver disease or a history of hepatic dysfunction.
• Abnormal Uterine Bleeding: Patients with undiagnosed abnormal genital bleeding.
• Ovarian Cysts: Presence of ovarian cysts not related to polycystic ovary syndrome.
• Hormone-Sensitive Malignancies: Patients with known or suspected estrogen-dependent neoplasia, such as endometrial carcinoma.
• Hypersensitivity: Known hypersensitivity to clomiphene citrate or any component of the formulation.

Possible side effect

While many patients tolerate Fertomid well, a range of side effects can occur, primarily related to its anti-estrogenic and hormonal effects.

• Very Common (>10%): Vasomotor flushes (“hot flashes”), abdominal discomfort or bloating.
• Common (1-10%): Ovarian enlargement, breast tenderness, nausea and vomiting, headache, visual disturbances (blurring, spots, photophobia), abnormal uterine bleeding, dizziness, insomnia, depression, hair loss (alopecia), weight gain.
• Uncommon (<1%): Ovarian hyperstimulation syndrome (OHSS), tachycardia, allergic reactions (skin rashes, urticaria), increased urinary frequency.

Drug interaction

Concurrent use of Fertomid with other medications should be carefully evaluated.

• GnRH Analogs (e.g., Leuprolide): Concomitant use can alter the pituitary response to clomiphene.
• Estrogens: May antagonize the effects of Fertomid.
• Danazol: May inhibit the ovulation-inducing effect of clomiphene.
• Thyroid Hormones: Thyroid disorders can affect fertility; management of thyroid levels may be necessary but no direct pharmacokinetic interaction is well-documented.
• Metformin: Often used concomitantly in PCOS patients; no significant interaction noted, and the combination can be synergistic in inducing ovulation.

Missed dose

Strict adherence to the prescribed 5-day regimen is critical for efficacy. If a dose is missed, the patient should contact their physician for guidance. The general advice is:

• Do not double the dose to make up for a missed one.
• If the missed dose is remembered within 12 hours, take it immediately.
• If it is almost time for the next dose, skip the missed dose and resume the normal schedule.
• Inform the treating physician, as the cycle may need to be canceled or the monitoring schedule adjusted.

Overdose

There is no specific antidote for clomiphene citrate overdose. Symptoms of overdose are likely to be an exaggeration of its known pharmacological effects, including severe nausea and vomiting, vasomotor flushes, visual disturbances, ovarian enlargement with abdominal pain, and potentially ovarian hyperstimulation syndrome (OHSS). Management is supportive and symptomatic. Gastric lavage may be considered if ingestion was recent. Careful monitoring of vital signs and ovarian size via ultrasound is imperative.

Storage

• Store at room temperature (15°C - 25°C or 59°F - 77°F).
• Protect from light and moisture.
• Keep in the original blister pack until the moment of use.
• Keep out of reach of children and pets.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The efficacy and side effect profile can vary significantly from individual to individual.

Reviews

• Clinical Efficacy (4.5/5): “As a reproductive endocrinologist, Fertomid remains my first-line pharmacological intervention for WHO Group II anovulation. Its predictable response in a majority of patients and oral bioavailability make it an indispensable tool. Monitoring is key to maximizing success and minimizing risks like multiples.” – Dr. E. Lawson, MD, REI.
• Patient Experience (3.8/5): “The hot flashes were intense, but following my doctor’s monitoring schedule precisely led to a successful ovulation on the 100mg dose. It’s a challenging emotional journey, but for us, it was worth it. The 5-day pill course is far easier to manage than injections.” – Sarah T., treated for PCOS.
• Safety Profile (4.0/5): “While the side effects are notable and the contraindications must be strictly heeded, when used appropriately in the correct patient population, Fertomid has a decades-long record of being a relatively safe and effective agent. The link to ovarian cancer with prolonged use necessitates limiting treatment duration.” – Clinical Pharmacologist Review.
• Comparative Analysis (4.2/5): “For its intended purpose, it is highly effective. It doesn’t have the high success rates per cycle of IVF, but it also doesn’t carry the same financial burden or physical invasiveness. It successfully bridges the gap between lifestyle intervention and advanced ART for countless patients.” – Fertility Clinic Outcome Report.