IVF-C Injection (Human Chorionic Gonadotropin (hCG))

Table of Content

IVF-C is a preparation of human chorionic gonadotropin (hCG) extracted and purified from the urine of pregnant women. hCG is a water-soluble polypeptide hormone produced by the human placenta. Each vial of IVF-C contains 5000 IU of hCG.

The action of hCG is virtually identical to that of pituitary LH, although hCG also seems to have a small degree of FSH activity. In male, IVF-C is given in an attempt to stimulate the interstitial cells of the testes (cells of Leydig) to produce androgen and in female, in the second phase of the cycle, to maintain the functional integrity of the corpus luteum and to stimulate its secretion of progesterone. In ART, IVF-C should be administered for the final development and maturation of the ovarian follicles and to trigger ovulation. Therefore, IVF-C must be given following the administration of Urofollitropin, Menotropin or rFSH.

In the treatment of prepubertal cryptorchidism, doses regimens vary widely, but doses usually range from 500 to 4000 units three times weekly by intramuscular injections. For male infertility associated with hypogonadotropic hypogonadism, there is considerable variation in the dosage regiment, and doses have varied from 500 to 4000 units two to three times weekly.

For oligospermia and asthenospermia, 5000 IU of IVF-C should be administered in combination with 500 IU of menotropin everyday for 90~120 days.

In case of habitual abortion, 5000 IU of IVF-C should be administered every other day during the 2nd~3rd months of pregnancy and 1000IU should be continued to be administered for the following 2 months.

For anovulatory infertility, the ovulation should be induced by administering 5000-10,000 IU of IVF-C on the first day after the last dose of menotropin/FSH.

For intramuscular use only

IVF-C is a preparation of human chorionic gonadotropin (hCG) extracted and purified from the urine of pregnant women. hCG is a water-soluble polypeptide hormone produced by the human placenta.

The action of hCG is virtually identical to that of pituitary LH, although hCG also seems to have a small degree of FSH activity. In male, IVF-C is given in an attempt to stimulate the interstitial cells of the testes (cells of Leydig) to produce androgen and in female, in the second phase of the cycle, to maintain the functional integrity of the corpus luteum and to stimulate its secretion of progesterone.

In ART, IVF-C should be administered for the final development and maturation of the ovarian follicles and to trigger ovulation. Therefore, IVF-C must be given following the administration of Urofollitropin, Menotropin or rFSH.

Appearance of powder: white to off-white lyophilisation cake

Appearance of solvent: clear colourless solution

Composition

Each vial of IVF-C Inj. is accompanied by a solvent vial containing 1mL of isotonic, sterile and pyrogen-free sodium chloride for injection

1 vial of IVF-C contains:

Active ingredient: human chorionic gonadotropin (hCG) USP … 5000 IU

Excipient: D-Mannitol … 20.0 mg

pH adjuster: Dibasic sodium phosphate … q.s.

pH adjuster: Monobasic sodium phosphate … q.s.

Each vial of solvent contains:

Sodium Chloride for Injection IP … 1 mL

Description

White or almost white lyophilized powder for injection in a clear vial.

Indications

Anovulatory infertility, cryptorchidism, corpus luteum insufficiency, oligospermia, hypogonadotropic hypogonadism, habitual abortion, asthenospermia.

Dosage and Administration

For Males

Cryptochidism and Hypogonadotropin Hypogonadism

In the treatment of prepubertal cryptorchidism, doses regimens vary widely, but doses usually range from 500 to 4000 units three times weekly by intramuscular injections. For male infertility associated with hypogonadotropic hypogonadism, there is considerable variation in the dosage regiment, and doses have varied from 500 to 4000 units two to three times weekly. An agent with follicle-stimulating activity is often added to enable normal spermatogenesis.

Oligospermia and Asthenospermia:

5000 IU of IVF-C should be administered in combination with 500 IU of menotropin everyday for 90~120 days.

For Females

Habitual abortion

5000 IU of IVF-C should be administered every other day during the 2nd~3rd months of pregnancy and 1000IU should be continued to be administered for the following 2 months.

Anovulatory infertility

The ovary should be stimulated by the administration of proper amount of menotropin/rFSH under physician’s indication during the period caused by hypopituitarism or decreased ovarian sensitivity to pituitary gonadotropin. This administration should be continued until estrogen reaches appropriate level. The ovulation should be induced by administering 5000-10,000 IU of IVF-C on the first day after the last dose of menotropin/FSH.

Contraindications

  • Patients with prostatic carcinoma or other androgen-dependent neoplasm and who are suspicious to have such diseases
  • Patients with a prior allergic reaction to gonadotropins
  • Patients with precocious puberty

Warnings and Precautions

IVF-C should be cautiously administered to following patients.

  • Patients with prostatomegaly
  • Patients with epilepsy, migraine, asthma, and cardiac or renal disease (Fluid retention, edema, and so on may occur since androgen production is promoted.)

General Precautions

In case hCG is used after or in conjunction with a follicle stimulating hormone preparation to treat female infertility, ovarian hyperstimulation symptom such as Meigs syndrome accompanied by ovarian swelling, rupture of tumid ovary, ascites, and pleural effusion may occur and caution should be made with followings.

  1. Since there is a risk of multiple birth, patients should be informed of this previously.
  2. Whether patients have subjective symptoms such as abdominal pain, abdominal discomfort, vomiting, lumbago, etc. should be cautiously monitored.
  3. Whether patients have ovarian swelling should be confirmed by an internal examination.

Precautions on Application

  1. Because a precipitation can be made by ethanol, etc., a syring should be used after disinfecting and washing with a small amount of solvent accompanied.
  2. The reconstituted solution should be used immediately.

Adverse Effects

Shock

Because shock may occur in rare cases, sufficient monitoring should be made. In case facial blush, heartburn, dyspnea, etc. occur, the administration should be discontinued and proper treatments made.

Hypersensitivity

Since rash and so on may occur, the administration should be discontinued in case of this.

Psychoneural System

Dizziness, excitation, insomnia, depression, fatigue, etc. may occur.

Circulatory System

Thrombosis and cerebral thrombosis can rarely occur.

Continuous Administration for A Long Time

Hypersexuality, sustained penis erection, acne, and gynecomastia can occur in male and signs of masculinization such as trachyphonia, polytrichia, clitorism, acne, etc. in female.

Others

In case signs of precocious puberty occur during the administration to prepubertal patients, administration should be discontinued. Pain at site of injection can be caused by intramuscular injection

How Supplied

5000 IU: 1 vial with solvent vial

Storage Condition

Store in hermetic container at or below 20°C. Protect from light. Keep out of reach of children.

Shelf Life

24 months