Indications:

Female sterility with hypo- or normogonadotropic ovarian insufficiency: stimulation of follicle growth.
Male sterility with hypo- or normogonadotropic hypogonadism: in combination with HCG to stimulate spermatogenesis.

Pharmacology: Human Menopausal Gonadotrophin (HMG) directly affects ovaries and testes. It has gametotropic and steroidogenic effects.

In ovaries: FSH increases follicle growth and estradiol production by aromatizing androgens under LH influence.
In testes: FSH transforms premature Sertoli cells to mature ones, aiding sperm development. High androgen concentration is required, achieved by prior HCG treatment. HMG is not effective orally; administered intramuscularly (i.m.) or subcutaneously (s.c.). Peak serum FSH occurs 6–48 hours (i.m.) and 6–36 hours (s.c.), with half-life ~51–56 hours. Excreted renally.

Dosage:

Females: 75–150 IU FSH daily i.m./s.c., adjusted by ovarian response (ultrasound, estradiol). Ovulation induced with 5000–10000 IU HCG 1–2 days after last HMG dose.
Males: Initially 2 × 5000 IU HCG weekly until testosterone normalizes, then add HMG (3 × 75–150 IU FSH + 75–150 IU LH weekly).

Administration: Intramuscular or subcutaneous injection.

Patient Selection:

Females: Full gynecological/endocrinological evaluation, rule out pregnancy, primary ovarian failure, uterine/tubal pathology, endometrial abnormalities.
Males: Documented lack of pituitary function, low testosterone, low gonadotropins. Rule out primary testicular failure.

Interactions: Unknown; can be injected with HCG in male infertility.

Contraindications:

Females: Pregnancy, ovarian enlargement/cysts (non-PCOS), unexplained bleeding, uterine/ovarian/breast tumors, hypersensitivity, high FSH (primary ovarian failure), uncontrolled thyroid/adrenal dysfunction, infertility causes other than anovulation.
Males: Prostate carcinoma, testicular tumors, normal gonadotropin levels, primary testicular failure, infertility other than hypogonadotropic hypogonadism.

Pregnancy & Lactation: Not indicated during pregnancy or lactation.

Precautions & Warnings: Risk of miscarriage, multiple or ectopic pregnancies. Monitor ovarian activity closely (ultrasound, estradiol). Stop treatment if hyperstimulation occurs. Severe ovarian hyperstimulation syndrome may be life-threatening.

Overdose Effects: Can cause ovarian hyperstimulation. Severity ranges from mild enlargement to life-threatening cysts, ascites, hydrothorax, thromboembolic events. Requires close monitoring, hospitalization if severe.

Undesirable Effects: Febrile reactions, flu-like symptoms, GI upset, injection site reactions, rash, dizziness, tachycardia, dyspnea. Reported pregnancy outcomes: ectopic pregnancy, congenital abnormalities.

Therapeutic Class: Female sex hormones

Storage Conditions: Store at 2–8°C. Do not freeze. Below 25°C for max 3 months. Protect from light, keep dry. Use reconstituted solution immediately; discard remainder.