|In the female:• In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiplets.• Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.• Rates of pregnancy loss in women undergoing ART are higher than in the normal population. • The presence of uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders) should be ruled out.• The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. There are no indications that the use of gonadotrophins during ART is associated with an increased risk of congenital malformations.• Unwanted ovarian hyperstimulationIn patients treated for subfertility due to anovulation or impaired follicular ripening, the prior administration of an FSH-containing preparation may lead to unwanted ovarian hyperstimulation. Therefore ultrasonic assessment of follicular development and determinations of estradiol levels should be performed prior to FSH-treatment and at regular intervals during FSH-treatment. Estradiol levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reach excessively high values. The diagnosis of unwanted ovarian hyperstimulation may be confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of a treatment preparing for IVF/ET, GIFT or ICSI), the administration of the FSH-containing preparation should be discontinued immediately. In that case pregnancy should be avoided and Pregnyl must not be given, because the administration of an LH-active gonadotropin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation syndrome (OHSS). This warning is particularly important with respect to patients with polycystic ovarian disease. Clinical symptoms of mild ovarian hyperstimulation syndrome are gastro-intestinal problems (pain, nausea, diarrhoea), painful breasts, and mild to moderate enlargement of ovaries and ovarian cysts. Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with ovarian hyperstimulation syndrome. In rare cases severe ovarian hyperstimulation syndrome occurs, which may be life-threatening. This is characterized by large ovarian cysts (prone to rupture), ascites, weight gain, often hydrothorax and occasionally thromboembolic phenomena. • Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity (Body Mass Index > 30 kg/m2) or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. In these women the benefits of IVF treatment need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. • Pregnyl should not be used for body weight reduction. HCG has no effect on fat metabolism, fat distribution or appetite.In the male:Treatment with hCG leads to increased androgen production. Therefore:• Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production.• hCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Use should cease immediately in such cases. Skeletal maturation should be monitored regularly. A growth spurt may also be associated with use and this should be kept in mind particularly where epiphyseal growth is still potentially active.The product should be used with caution in patients with an allergic diathesis. A preliminary skin test may be of assistance in detecting hypersensitivity. This product should only be used under the supervision of a specialist, for the first administration, having available adequate facilities for appropriate laboratory monitoring.|
Patients on a controlled sodium diet:This medicinal product contains less than 1 mmol sodium (23 mg) per daily dose, i.e. essentially 'sodium-free'