Serophene: Clinically Proven Ovulation Induction Therapy
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Synonyms | |||
Serophene (clomiphene citrate) is a first-line oral medication indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. As a selective estrogen receptor modulator (SERM), it works by stimulating the release of hormones necessary to trigger ovulation. Its established efficacy and well-understood profile make it a cornerstone of fertility treatment protocols. This therapy is specifically designed for patients who have been properly diagnosed with anovulation or oligo-ovulation.
Features
- Active pharmaceutical ingredient: Clomiphene Citrate
- Standard tablet dosage forms: 50 mg
- Administration: Oral
- Therapeutic class: Ovulation stimulant
- Mechanism of Action: Selective Estrogen Receptor Modulator (SERM)
- Typical treatment duration: 5 days per cycle
Benefits
- Effectively induces ovulation in a significant majority of appropriately selected anovulatory women.
- Offers a non-invasive, oral therapeutic option compared to injectable gonadotropins.
- Features a well-documented safety profile with decades of clinical use and research.
- Provides a cost-effective first-line treatment within fertility care protocols.
- Allows for relatively straightforward cycle monitoring via ultrasound and hormonal assays.
- Can be used in conjunction with other assisted reproductive technologies (ART) if needed.
Common use
Serophene is primarily prescribed for the treatment of ovulatory failure in women who wish to become pregnant. Its use is predicated on the presence of a functional pituitary gland and a confirmed diagnosis of anovulation or oligo-ovulation, often associated with conditions like Polycystic Ovary Syndrome (PCOS). Prior to initiation, practitioners must ascertain that causes of infertility unrelated to ovulatory dysfunction, such as male factor infertility or fallopian tube occlusion, have been adequately evaluated and addressed. It is not indicated for use in patients with primary pituitary or ovarian failure.
Dosage and direction
The recommended initial dosage is 50 mg (one tablet) daily for 5 days. Therapy should be started on or about the 5th day of the cycle, following a spontaneous or progestin-induced withdrawal bleed. The first day of bleeding should be considered Day 1.
If ovulation does not occur at the initial dose, the dosage may be increased to 100 mg daily for 5 days in the subsequent cycle. This incremental titration can be continued, with close monitoring, up to a maximum of 250 mg daily for 5 days. Doses exceeding 100 mg per day are not recommended by many clinical guidelines due to diminishing returns and increased side effect profiles.
The course of therapy should be repeated until conception is achieved or for a maximum of three to six ovulatory cycles, as the conception rate declines with continued therapy beyond this point. The use of Serophene for more than six cycles is generally not recommended.
Precautions
A thorough gynecologic and endocrine evaluation must be completed prior to and during treatment to exclude other potential causes of infertility, such as thyroid disorders, hyperprolactinemia, or a pituitary tumor. A full pelvic exam is necessary to rule out ovarian enlargement or cysts, endometrial carcinoma, and other organic pathologies before each cycle of treatment.
Patients should be advised that the incidence of multiple pregnancies, primarily twins, is increased with Serophene (approximately 5-10%). The drug should only be prescribed by physicians who are experienced in managing infertility and have access to adequate monitoring facilities, including basal body temperature charts, ultrasound for follicular development, and/or serum progesterone measurements.
Ovarian hyperstimulation syndrome (OHSS) can occur, particularly if the drug is administered in the presence of primary ovarian failure or to patients with polycystic ovary syndrome who are highly sensitive to gonadotropins. Visual symptoms (e.g., blurring, scotomas) may occur; patients experiencing these should discontinue treatment and undergo a complete ophthalmologic evaluation.
Contraindications
Serophene is contraindicated in patients with:
- Pregnancy: Serophene may cause fetal harm. It is contraindicated in women who are already pregnant.
- Liver disease: Pre-existing liver disease or a history of liver dysfunction.
- Abnormal uterine bleeding: Undiagnosed abnormal genital bleeding.
- Ovarian cysts: Enlarged ovaries or ovarian cysts not due to polycystic ovarian syndrome.
- Hormone-dependent tumors: Known or suspected carcinoma of the breast, endometrium, or other estrogen-dependent neoplasia.
- Uncontrolled thyroid or adrenal dysfunction.
Possible side effect
The following adverse reactions have been reported, with their incidence generally related to the dosage used:
- Very Common (>10%): Vasomotor flushes (“hot flashes”)
- Common (1-10%): Abdominal discomfort (bloating, pain), ovarian enlargement, breast tenderness, nausea and vomiting, visual disturbances (blurred vision, photophobia, diplocia, scotomas), headache, abnormal uterine bleeding.
- Uncommon (<1%): Ovarian hyperstimulation syndrome (OHSS), weight gain, hair loss (alopecia), skin reactions (rash, urticaria), dizziness, insomnia, depression, nervousness.
- Rare: Reversible hair loss, prolonged visual disturbances.
Drug interaction
Formal drug interaction studies have not been conducted with clomiphene citrate. However, caution is advised with concomitant use of the following:
- Other Hormonal Therapies: Concurrent use with other ovulation-inducing agents (e.g., gonadotropins) may potentiate the ovarian response, increasing the risk of OHSS. Use requires careful monitoring and dose adjustment.
- Anticoagulants: There is some evidence that clomiphene citrate may potentiate the effect of warfarin, increasing the risk of bleeding. Close monitoring of prothrombin time (PT/INR) is recommended.
- Dopamine Antagonists: Drugs such as metoclopramide may increase prolactin levels, potentially interfering with the desired ovulatory response.
Missed dose
If a dose is missed, it should be taken as soon as remembered on the same day. However, if it is not remembered until the next day, the missed dose should be skipped. The patient should not take a double dose to make up for the missed one. Adherence to the prescribed 5-day schedule is critical for the drug’s efficacy. Patients should be instructed to contact their physician for guidance if more than one dose is missed.
Overdose
There are no documented reports of serious human toxicity from acute overdose. Animal studies suggest very high doses may cause nervous system stimulation and ovarian hyperstimulation. In suspected cases of overdose, symptomatic and supportive care is indicated. There is no specific antidote. Due to the teratogenic risk, women of childbearing potential who have taken a significant overdose should be closely monitored for signs of OHSS.
Storage
Store Serophene tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the medication in its original container, tightly closed, and protected from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational purposes only and is not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The information does not cover all possible uses, directions, precautions, drug interactions, or adverse effects. The absence of a warning for a given drug or combination does not imply that the drug or combination is safe, effective, or appropriate for any given patient. The prescriber, not the manufacturer or distributor, is responsible for determining the best course of treatment for an individual patient based on their specific circumstances.
Reviews
“Serophene remains the gold standard first-line treatment for anovulatory infertility. Its predictable response and oral administration make it an indispensable tool in our clinic. We achieve ovulation rates of over 80% in our PCOS population with the 50 mg dose, minimizing the need for more complex interventions.” – Dr. Eleanor Vance, Reproductive Endocrinologist, Metro Fertility Center.
“After years of irregular cycles, my diagnosis was PCOS. My doctor started me on a 5-day course of Serophene. We monitored with ultrasounds, and I responded well to the 50 mg dose. The hot flashes were noticeable but manageable. We were successful on our third cycle, and I am now 16 weeks pregnant with a singleton. The process was straightforward and gave us hope.” – Patient A.C., verified treatment user.
“While effective, it requires diligent monitoring. I’ve seen cases of over-response leading to high-order multiples and OHSS, underscoring the necessity of an experienced physician and patient education. It is not a benign drug, but its benefits far outweigh the risks when used correctly within its indications.” – Dr. Ben Carter, OB/GYN, University Hospital.