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Clomiphene: Drug information

Clomiphene: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Clomiphene: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Clomid
Brand Names: Canada
  • Clomid [DSC]
Pharmacologic Category
  • Ovulation Stimulator;
  • Selective Estrogen Receptor Modulator (SERM)
Dosing: Adult
Ovulation induction

Ovulation induction: Note: Time intercourse to coincide with the expected time of ovulation (usually 5 to 10 days after a clomiphene course).

Initial course: Oral: 50 mg once daily for 5 days. Begin on or about the fifth day of cycle if progestin-induced bleeding is scheduled or spontaneous uterine bleeding occurs prior to therapy. Therapy may be initiated at any time in patients with no recent uterine bleeding.

Dose adjustment: Oral: Subsequent doses may be increased to 100 mg once daily for 5 days only if ovulation does not occur at the initial dose. A lower dose of 25 mg may be used in patients sensitive to clomiphene or who consistently develop large ovarian cysts (Ref).

Repeat courses: If needed, the 5-day cycle may be repeated as early as 30 days after the previous one. Exclude the presence of pregnancy. The lowest effective dose should be used.

Maximum dose/duration of therapy: Oral: 100 mg once daily for 5 days for up to 6 cycles. Discontinue if ovulation does not occur after 3 courses of treatment; or if 3 ovulatory responses occur but pregnancy is not achieved. Long-term therapy (>6 cycles) is not recommended. Re-evaluate if menses does not occur following ovulatory response. Doses >100 mg once daily are not recommended by the manufacturer; however, some experienced clinicians use a maximum dose of 150 mg once daily. Higher doses (200 to 250 mg once daily) have been used in select patients but are generally not recommended due to limited data and experience (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

Use is contraindicated in patients with a history of liver disease or dysfunction.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Endocrine & metabolic: Ovary enlargement (14%)

1% to 10%:

Central nervous system: Headache (1%)

Endocrine & metabolic: Hot flash (10%)

Gastrointestinal: Abdominal distention (≤6%), abdominal distress (≤6%), bloating (≤6%), nausea (≤2%), vomiting (≤2%)

Genitourinary: Breast disease (discomfort: 2%), abnormal uterine bleeding (1%)

Ophthalmic: Visual disturbance (2%)

<1%, postmarketing/case reports: Accommodation disturbance, acne vulgaris, alopecia, anxiety, arthralgia, back pain, cardiac arrhythmia, cataract, cerebrovascular accident, chest pain, constipation, depression, dermatitis, diarrhea, dizziness, dry hair, dyspnea, ectopic pregnancy, edema, endometriosis, endometrium disease (reduced thickness), erythema, erythema multiforme, erythema nodosum, eye pain, fatigue, fever, hepatitis, hypersensitivity reaction, hypertension, hypertrichosis, hypertriglyceridemia, increased appetite, increased serum transaminases, increased urine output, insomnia, irritability, leukocytosis, macular edema, migraine, mood changes, myalgia, neoplasm, nervousness, optic neuritis, ovarian cyst, ovarian hemorrhage, ovarian hyperstimulation syndrome, palpitations, pancreatitis, paresthesia, phlebitis, photopsia, pruritus, psychosis, pulmonary embolism, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, seizure, severe abdominal pain, skin rash, syncope, tachycardia, thrombophlebitis, thyroid disease, tinnitus, urinary frequency, urticaria, uterine hemorrhage, vaginal dryness, vertigo, vision loss (temporary/prolonged), vitreous detachment (posterior), weakness, weight gain, weight loss

Contraindications

Hypersensitivity to clomiphene citrate or any of its components; liver disease or history of liver disease; abnormal uterine bleeding; enlargement or development of ovarian cyst (not due to polycystic ovarian syndrome); uncontrolled thyroid or adrenal dysfunction; presence of an organic intracranial lesion such as pituitary tumor; pregnancy

Canadian labeling: Additional contraindications (not in the US labeling): Hormone-dependent tumors (Clomid); thrombophlebitis, uterine fibroids, mental depression (Serophene)

Warnings/Precautions

Concerns related to adverse effects:

• Hyperlipidemia: Patients with, or a family history of, hyperlipidemia may be at increased risk of hypertriglyceridemia. High doses of clomiphene or long durations of therapy may increase risk this risk. Pancreatitis has been reported. Pretreatment screening of triglycerides is recommended.

• Ovarian enlargement: May be accompanied by abdominal distention or abdominal pain and generally regresses without treatment within a few days or weeks after therapy discontinuation. If ovaries are abnormally enlarged, withhold therapy until ovaries return to pretreatment size; reduce clomiphene dose and duration of future cycles.

• Ovarian hyperstimulation syndrome: Ovarian hyperstimulation syndrome (OHSS) is a rare, exaggerated response to ovulation induction therapy (Fiedler 2012; SOGC [Corbett 2014]). This syndrome may begin within 24 hours of human chorionic gonadotropin treatment but may become most severe 7 to 10 days after therapy (SOGC [Corbett 2014]). Mild/moderate OHSS signs/symptoms may include abdominal distention/discomfort, diarrhea, nausea, vomiting, and mild/moderate enlargement of ovaries/ovarian cysts. Severe OHSS signs/symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased CrCl, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Fiedler 2012; SOGC [Corbett 2014]). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; SOGC [Shmorgun 2017]).

• Visual disturbances: Blurring or other visual symptoms may occur; symptoms may increase with higher doses or duration of therapy and in some cases may be irreversible. These visual disturbances may render some activities more hazardous than normal (eg, operating machinery or driving). Discontinue therapy and promptly evaluate patients with visual disturbances.

Disease-related concerns:

• Ovarian cancer: Prolonged use may increase the risk of borderline or invasive ovarian cancer.

• Polycystic ovarian syndrome: Use with caution in patients unusually sensitive to pituitary gonadotropins (eg, polycystic ovarian syndrome); a lower dose may be necessary.

• Uterine fibroids: Use caution in patients with uterine fibroids, may cause further enlargement.

Other warnings/precautions:

• Appropriate use: To minimize risks, use only at the lowest effective dose for the shortest duration of therapy (especially for the first course of therapy).

• Experienced physician: Use should be supervised by physicians who are thoroughly familiar with infertility problems and their management.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as citrate:

Clomid: 50 mg [scored; contains corn starch]

Generic: 50 mg [DSC]

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Clomid Oral)

50 mg (per each): $8.58

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as citrate:

Clomid: 50 mg [DSC]

Administration: Adult

The total daily dose should be taken at one time to maximize effectiveness (Ref).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Use: Labeled Indications

Treatment of ovulatory dysfunction: Treatment of ovulatory dysfunction in patients desiring to become pregnant.

Medication Safety Issues
Sound-alike/look-alike issues:

ClomiPHENE may be confused with clomiPRAMINE, clonidine

Clomid may be confused with clonidine

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

International issues:

Serophene [multiple international markets] may be confused with Sarafem brand name for FLUoxetine [US and Puerto Rico]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Fluoroestradiol F18: Selective Estrogen Receptor Modulators may diminish the diagnostic effect of Fluoroestradiol F18. Risk X: Avoid combination

Ospemifene: Selective Estrogen Receptor Modulators may enhance the adverse/toxic effect of Ospemifene. Ospemifene may also enhance adverse/toxic effects of other Selective Estrogen Receptor Modulators. Risk X: Avoid combination

Reproductive Considerations

Clomiphene is indicated for use in patients desiring to become pregnant. Patients with polycystic ovary syndrome (PCOS), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post oral contraceptive amenorrhea, and some cases of secondary amenorrhea of undetermined cause may most likely benefit from clomiphene therapy. Advise patients of the potential risk for multiple births before starting treatment.

Clomiphene may be used for ovulation induction in patients diagnosed with PCOS and anovulatory infertility (and no other infertility factors) to improve ovulation and pregnancy rate; use may be preferred in patients with a BMI ≥30 kg/m2. Exclude pregnancy prior to each treatment course. The risk of multiple pregnancy may be increased (Teede 2018).

Clomiphene has been evaluated for use in males with infertility; however, additional studies are needed to determine efficacy and dosing (AUA/ASRM [Schlegel 2021]; Huijben 2022; Puia 2022). Clomiphene is not approved for the treatment of male infertility; testicular tumors and gynecomastia have been observed following use of clomiphene in males.

Pregnancy Considerations

Use is contraindicated in patients who are already pregnant.

The incidences of adverse fetal effects or spontaneous abortion following maternal use of clomiphene for ovulation induction are similar to the general population.

Breastfeeding Considerations

Clomiphene is present in breast milk.

Data related to the presence of clomiphene in breast milk are available from a study evaluating a method for determining the presence of clomiphene and other medications in breast milk. Breast milk was sampled over 24 hours following the last dose of clomiphene to 1 patient. Using a mean milk concentration of 300 ng/mL, authors of the study calculated the estimated daily infant dose of clomiphene via breast milk to be 45 mcg/kg/day, providing a relative infant dose (RID) of 2.2% compared to a weight-adjusted maternal dose of 2,040.8 mcg/kg/day. The highest breast milk concentration reported was 582.5 ng/mL (Monfort 2021). In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

The manufacturer recommends that caution be used if administered to patients who are breastfeeding. Clomiphene may decrease lactation.

Monitoring Parameters

Prior to therapy: serum estrogen. Rule out primary pituitary or ovarian failure, endometriosis/endometrial carcinoma, adrenal disorders, thyroid disorders, hyperprolactinemia, and male infertility. Serum triglycerides.

Pelvic exam prior to each course of therapy; pregnancy test prior to repeat courses; ovulation (may include serum progesterone; urinary luteinizing hormone; ultrasound) (SOGC [Smithson 2018]).

OHSS: Monitoring of hospitalized patients should include abdominal circumference, albumin, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, serum creatinine, urine output, urine specific gravity, vital signs, weight (daily or as necessary) and liver enzymes (weekly) (SOGC [Shmorgun 2017]).

Mechanism of Action

Clomiphene is a racemic mixture consisting of zuclomiphene (~38%) and enclomiphene (~62%), each with distinct pharmacologic properties. Clomiphene acts at the level of the hypothalamus, occupying cell surface and intracellular estrogen receptors (ERs) for longer durations than estrogen. This interferes with receptor recycling, effectively depleting hypothalamic ERs and inhibiting normal estrogenic negative feedback. Impairment of the feedback signal results in increased pulsatile GnRH secretion from the hypothalamus and subsequent pituitary gonadotropin (FSH, LH) release, causing growth of the ovarian follicle, followed by follicular rupture (ASRM 2013; Dickey 1996).

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Ovulation: 5 to 10 days following course of treatment

Duration: Effects are cumulative; ovulation may occur in the cycle following the last treatment (Dickey 1996)

Absorption: Readily absorbed

Metabolism: Hepatic; undergoes enterohepatic recirculation (Goldstein 2000)

Half-life elimination: ~5 days (Goldstein 2000)

Time to peak, plasma: ~6 hours (Goldstein 2000)

Excretion: Primarily feces (42%); urine (8%); some excretion may occur for up to 6 weeks after therapy is discontinued

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Clomid | Fertab | Fertomid | Serophene;
  • (AR) Argentina: Clomifem | Genozym | Serofene | Tocofeno;
  • (AT) Austria: Clomiphen arcana | Serophene;
  • (AU) Australia: Clomhexal | Clomid | Clomiphene | Fermil | Serophene;
  • (BD) Bangladesh: Clomid | Clostilbegyt | Clovul | Comipen | Fermid | Fertil | Ova-mit | Ovuclon | Reomen | Serpafar;
  • (BE) Belgium: Clomid | Pergotime;
  • (BF) Burkina Faso: Clomid | Clomifex | Jesper;
  • (BG) Bulgaria: Clomiphene citrate | Clostilbegyt | Serophene | Serpafar;
  • (BR) Brazil: Clomid | Indux | Serofene | Serophene;
  • (CH) Switzerland: Clomid;
  • (CI) Côte d'Ivoire: Clomifex | Fertab | Ovulet;
  • (CL) Chile: Serofene | Zimaquin;
  • (CN) China: Clomifene | Fertilan | Serophene;
  • (CO) Colombia: Omifin | Serofene | Tocofeno | Zimaquin;
  • (CZ) Czech Republic: Clomhexal | Clostilbegyt | Gravosan | Serophene;
  • (DE) Germany: Clomhexal | Clomifen | Clomifen Ferring | Clomifen Galen | Pergotime;
  • (DO) Dominican Republic: Clofen | Clomifeno | Nefimol | Serofene;
  • (EC) Ecuador: Ova mit | Ovamit | Serophene | Tocofeno | Zimaquin;
  • (EE) Estonia: Clomid | Clomifen | Clomifen ratiopharm | Clomifert | Clomiphene citrate | Clostilbegyt | Serophene;
  • (EG) Egypt: Clofen | Clomid | Clomifert | Clomiphene | Clostilbegyt | Tecnovula;
  • (ES) Spain: Clomifeno | Omifin;
  • (FI) Finland: Clomifen;
  • (FR) France: Clomid | Pergotime;
  • (GB) United Kingdom: Clomid | Clomifene | Clomiphene | Clomiphene kent | Clophene | Serophene;
  • (GR) Greece: Clomiphene citrate | Serpafar;
  • (HK) Hong Kong: Clomid | Clomiphene citrate | Clostilbegyt | Duinum | Fertilan | Fertiphen | Ova-mit | Ovulet | Serophene;
  • (HU) Hungary: Clostilbegyt | Serophene;
  • (ID) Indonesia: Blesifen | Clomid | Clomifene | Clomifil | Dipthen | Fensipros | Fertilphen | Fertin | Genoclom | Gp fertil | Mestrolin | Ofertil | Pinfetil | Profertil | Provula | Serophene;
  • (IE) Ireland: Clomid;
  • (IL) Israel: Ikaclomin;
  • (IN) India: Cee cee | Cerofene | Clofert | Clome | Clomi | Clomidac | Clominine | Clomitrop | Clophene | Clopreg | Clorek | Ferpill | Fertex | Fertik | Fertil | Fertilin | Fertipath | Fertoben | Fertomid | Ferton | Fertotab | Fertyl | Fertyl-m | Fetrop | Folistim | Fulfyl | Genifene | Ovagen | Ovipreg | Ovitec | Ovobel | Ovofar | Pifert | Pregmate | Pregmate m | Refert | Rejun | Siphene | Tevrol | X clo;
  • (IT) Italy: Clomid | Serofene;
  • (JO) Jordan: Arcafen | Clomid | Clomifert | Clomoval | Clostilbegyt | Duinum | Infantril | Ovamit;
  • (JP) Japan: Clomid | Orifen | Phemilon | Serofen | Spacromin;
  • (KE) Kenya: Ciphene | Clomitab | Ovuclon | Praclomide;
  • (KR) Korea, Republic of: Cliphen | Clomiphene | Clophen | Lomifene | Serophene;
  • (KW) Kuwait: Clomid | Clomiphene | Fertab | Ovamit | Serophen;
  • (LB) Lebanon: Clomid | Clomifert | Fertab | Prolifen | Serofene;
  • (LT) Lithuania: Clomid | Clomish | Clostilbegyt | Gravosan | Serophene | Serpafar;
  • (LU) Luxembourg: Clomid | Pergotime;
  • (LV) Latvia: Clomid | Clomifen | Clomiphene citrate | Clostilbegyt | Gravosan | Serophene | Serpafar;
  • (MA) Morocco: Clomid;
  • (MX) Mexico: Clomifeno | Fentocile | Moments | Omifin | Serophene;
  • (MY) Malaysia: Axcel Clomiphene | Clomid | Clomiphen | Clomiphene | Clostilbegyt | Duinum | Ovamit | Ovinum | Phenate | Profertil | Serophene | Sunophene;
  • (NG) Nigeria: Clocef k | Clomibex | Clomid | Clomifene | Heclo | Namet | Ostone | Ovumine;
  • (NL) Netherlands: Clomid | Clomifeencitr | Serophene;
  • (NO) Norway: Clomid | Clomifen | Clomifen ratiopharm | Clomivid | Pergotime;
  • (NZ) New Zealand: Clomid | Clomiphen | Phenate | Serophene;
  • (PE) Peru: Biogen | Serofene | Zimaquin;
  • (PH) Philippines: Clomene | Clomid | Clostil | Duinum | Fertab | Ferticlo | Fertimax | Fertyl | Omy | Ovamit | Ovulant | Ovulet | Ovumed | Pregina | Serophene;
  • (PK) Pakistan: Cerophene | Clocit | Clofer | Clomate | Clomedon | Clomid | Clomidex | Clominol | Clomitab | Clomocite | Clophen | Clostilbegyt | Duinum | Fallodox | Femeg | Fensipros | Fertab | Ferticlo | Fertomid | Florid | Hex | Hope | Ian | Lexofene | Lovin | Namet | Ova-mit | Ovafred | Ovarine-F | Ovi F | Ovulin | Profertil | Provuler | Serpafar;
  • (PL) Poland: Clomid | Clostilbegyt | Gravosan;
  • (PR) Puerto Rico: Clomid | Clomiphene citrate | Serophene;
  • (PT) Portugal: Dufine;
  • (PY) Paraguay: Anexin | Serofene | Zimaquin;
  • (QA) Qatar: Clomid | Fertab;
  • (RO) Romania: Clostilbegyt | Ova-mit;
  • (RU) Russian Federation: Clomid | Clomifene | Clostilbegyt | Serophen;
  • (SA) Saudi Arabia: Clomid | Fertab | Ova-mit;
  • (SE) Sweden: Pergotime;
  • (SG) Singapore: Clomid | Clomiphene | Clophene | Clostilbegyt | Duinum | Ovamit | Phenate | Serophene;
  • (SI) Slovenia: Duinum | Klomifen;
  • (SK) Slovakia: Clomhexal | Clostilbegyt | Gravosan | Serophene;
  • (TH) Thailand: Clomid | Duinum | Ferticlo | Omicite | Ovamit | Ovinum | Serophene | Serpafar | Zimaquin;
  • (TN) Tunisia: Clomid | Serpafar;
  • (TR) Turkey: Fertilin | Gonaphene | Klomen | Klomifen | Serophene;
  • (TW) Taiwan: Clomid | Clomifen | Clomiphene | Duinum | Focel | Getchild | Lomifen | Ova-mit | Serophene;
  • (UA) Ukraine: Clostilbegyt;
  • (UG) Uganda: Duinum | Fertomid | Ova-mit;
  • (UY) Uruguay: Clomid | Genozym | Serophene | Tocofeno;
  • (VE) Venezuela, Bolivarian Republic of: Clomifeno | Serofene | Zimaquin;
  • (VN) Viet Nam: Vacitus;
  • (ZA) South Africa: Clomid | Clomihexal | Fertab | Fertomid | Rubitab | Serophene;
  • (ZM) Zambia: Clomihexal | Ova-mit;
  • (ZW) Zimbabwe: Ova-mit
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