IVF-M is a natural, carefully purified, and freeze-dried human menopausal gonadotropin extracted from the urine of postmenopausal women. Each vial of IVF-M contains white sterile and pyrogen-free powder having follicle stimulating hormone (FSH) and luteinizing hormone (LH) activity in a ratio of approximately 1.
Composition
Each vial of IVF-M is accompanied by a solvent vial or ampoule containing 1 ml of isotonic, sterile and pyrogen-free sodium chloride for injection.
1 vial of IVF-M contains
Active ingredient : Excipient -------------------------------------------- 75 or 150 IU
pH adjuster : D-Mannitol ----------------------------------------- 20 or 20 mg
pH adjuster : Dibasic sodium phosphate ---------------------- q.s.
pH adjuster : Monobasic sodium phosphate ----------------- q.s
Description
hite or almost White lyophilized powder for injection.
Indications and Usage
Female: Primary & secondary amenorrhea. Hypomenorrhea, Anovulatory mensturation. Amenorrhea after delivery including Chiari-Frommel or Sheehan symptom (pituitary necrosis; after delivery), Argons-Castille syndrome (amenorrheal Galactorrhea).
As in the female, IVF-M stimulates the growth and the maturation of follicles and it induces an increase of the estrogen levels and a proliferation of the endometrium, IVF-M is indicated for the induction of ovulation with subsequent human chorionic gonadotropin (hCG, IVF-C) in the amenorrhoeic patient or anovulatory woman with regular or irregular cycles.
Male: Oligospermia, Azoospermia, Hypogonadism, Eunuchoidism.
As IVF-M, in the male stimulates the spermatogenesis by acting on production of the androgen binding protein in the seminiferous tubules of the Sertoli cells. IVF-M with concomitant IVF-C is indicated for the stimulation of spermatogenesis in men who have primary or secondary hypogonadotropic hypogonadism.
Dosage and Administration
Schedule A: 75 IU or 150 1U/day of menotropin (IVF-M) is intramuscularly administered for 10 days or until follicular activation test indicates the bleeding of Graafian follicile. Make an examination of vagina and cervical mucus every day or at every other day and stop die therapy when following indexes indicate the complete maturation of follicle.
- Examination of vagina: Eosinophil index.
- Examination of cervical mucus: Fern test & Shinnbarkeit.
Schedule B: 75 IU or 150 1U/day of menotropin (IVF-M) is administered intramuscularly for the first 4 days.
Make examination of vaginal membrane or cervical mucus. If the follicular activity increases around the 4th day of treatment, continue the treatment until maximal follicular activity occurs (see schedule A) and human chorionic gonadotropin (IVF-C) is given subsequently. If an adequate response is not achieved, increase the dose of IVF-M to 150 IU/day for the first 4 days.
2500 IU/day of hCG (IVF-C) is recommended to be given for 3 days 24-48 hours after last dose of IVF-M is administered. If the patient wishes to conceive, she is recommended to have coitus during the period when hCG (IVF-C) is given.
- Schedule A needs to be recommended a sensitivity test of individual patient for gonadotropin.
- Schedule B is economical but follicular response should be carefully monitored.
Warnings and Precautions
- Warnings : IVF-M should he used only by physicians’ description.
- Women : IVF-M should be precluded for the following cases in which effective response cannot be obtained, e.g.
- Ovarian dysgenesis
- Absent uterus
- Premature menopause
- Tubal occlusion
- Men: Since elevated FSH levels in men are indicative of primary testicular failure, such patients are unresponsive to IVF-M and IVF-C.
- Side effects
- In the female, a local reaction at the injection site, fever, and athralgia may be observed in rare cases.
- In the male, a combined treatment of IVF-M and IVF-C may cause gynecomastia.
- Circulatory system; Cerebral thrombosis can be caused.
- Drug interactions : In case that IVF-M is given to induce ovulation concomitantly with or subsequently to the ovarian stimulating hormone, excessive ovarian reaction such as Meigs syndrome accompanied by ovarian swelling, rupture of tumid ovary, ascites, hydrothorax may occur, and furthermore thrombosis, cerebral infraction due to the increase of activity in blood concentration or blood coagulation may also occur.
- Pregnant women: The relationship between LH administration and the birth of congenitally defective child has not been established yet.
Appropriate treatment for hypothyroidism, adrenocortical deficiency, hyperprolactin-aemia, or pituitary tumor should be given first. Semen analysis should be available before IVF-M treatment.
The possibility of ovarian hyper-stimulation can be minimized by sticking to recommended dosage and monitoring.
Excessive estrogenic responses to do not generally cause significant side effects unless IVF-C is given for the purpose of inducing ovulation. IVF-M and IVF-C should be withheld in case of high estrogenic response to them.
The incidence of multiple births following IVF-M and IVF-C has been variously reported between 10% and 40%.However, the majority of multiple births are twins.
Pregnancy failure by an abortion is higher in a normal population but comparable with the rates in women having other fertility problems. Congenital abnormalities are not increased by IVF-M.
The relationship between LH administration and the birth of congenitally defective child has not been established yet.
But according to die epidemiological report, there was a significant difference between the women who had delivered babies with congenital defects in heart and limbs and so on and the control group, in the frequency of LH and LH/FSH administration during the early stage of pregnancy.
Since it was also reported that the administration of IVF-M had been related with the masculation of external genitalia in female fetus and hypospadias in male fetus, it should be used only under physicians’ decision that benefits from the treatment are superior to risks during the first 4 months of pregnancy.
Solutions of IVF-M reconstituted in physiological sodium chloride should be used immediately after preparation
How Supplied
- 75 IU: 1, 2, 3, 5, 10, 20 vials with solvent ampoules/pack
- 150 IU: 1, 2, 3, 5, 10, 20 vials with solvent ampoules/pack
Storage Condition
Store in the light-resistant place at room temperature (1~30° C).
Shelf Life
24 months