General precautions: This product should be used under the medical and biological supervision.
Not for use in the treatment of amenorrhea if pregnancy is not desired.
Before starting treatment, the patients should be evaluated and precluded for anatomical abnormality of the reproductive system (primary ovarian failure) or other hormonal disorders (thyroid, adrenal, diabetes, etc.).
Response is monitored by measuring the serum estradiol levels and by ovarian ultrasound during ovulation induction with hCG following IVF-M HP treatment. Such direct monitoring will minimize the risk of OHSS and multiple pregnancy, and it is useful to monitor the follicular maturation and development, and to determine the timing of hCG administration. Also, indirect parameters as follows may be combined: Examinations of changes in the vaginal cytology, appearance and volume of the cervical mucus, spinnbarkeit, ferning of cervical mucus.
The clinical confirmation of ovulation is obtained by direct or indirect indices of progesterone production such as a rise in basal body temperature, increase in serum progesterone, and menstruation following the shift in basal body temperature. Additionally, fluid in the cul-de-sac, ovarian sign, collapsed follicle, secretory endometrium can be the evidence of ovulation by the ultrasound examination.
Before starting treatment, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
There is considerable inter-patient variability in response to menotrophin administration.
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established if treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.
Women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (Body Mass Index ≥ 30kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotrophin. In these women, the benefits of gonadotrophin administration need to be weighed against the risks. It should be noted however, that pregnancy itself also carries an increased risk of thromboembolic events.
Use in Pregnancy: The incidence of pregnancy wastage by miscarriage or abortion caused by this product is comparable in women with other fertility problems.
Multiple pregnancy, especially high order, carries an increased risk of adverse maternal and perinatal outcomes.
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