Ovidrel Special Precautions

To date, there is no clinical experience with Ovidrel in other indications commonly treated with urine-derived human chorionic gonadotrophin.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Special precautions should be taken before administering Ovidrel to patients with clinically significant systemic disease where pregnancy could lead to worsening of the condition.
Patients undergoing ovarian stimulation are at an increased risk of developing ovarian hyperstimulation syndrome (OHSS) due to multiple follicular development.
Ovarian hyperstimulation syndrome may become a serious medical event characterised by large ovarian cysts, which are prone to rupture and the presence of ascites within a clinical picture of circulatory dysfunction. Ovarian hyperstimulation syndrome due to excessive ovarian response can be avoided by withholding hCG administration. Patients should be advised to refrain from coitus or use barrier methods for at least 4 days.
Careful monitoring of estradiol levels and ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, for all patients.
The risk of multiple pregnancy following assisted reproductive technologies is related to the number of embryos replaced. In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births (mostly twins) is increased compared with natural conception.
To minimize the risk of OHSS and of multiple pregnancy, ultrasound scans as well as estradiol measurements are recommended. In anovulation, the risk of OHSS is increased by a serum estradiol level >1500 pg/mL (5400 pmol/L) and >3 follicles of ≥14 mm in diameter. In assisted reproductive techniques, there is an increased risk of OHSS with a serum estradiol >3000 pg/mL (11,000 pmol/L) and ≥20 follicles of ≥12 mm in diameter. When the estradiol level is >5500 pg/mL (20,000 pmol/L) and when there are ≥40 follicles in total, it may be necessary to withhold hCG administration.
Adherence to recommended Ovidrel dosage, regimen of administration and careful monitoring of therapy will minimize the incidence of ovarian hyperstimulation and multiple pregnancy.
The rate of miscarriage in both anovulatory patients and women undergoing assisted reproductive techniques is higher than that found in the normal population, but comparable with the rates observed in women with other fertility problems.
During Ovidrel therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown. Self-administration of Ovidrel should only be performed by patients who are adequately trained and have access to expert advice.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed.
Use in pregnancy & lactation: Considering the indication, Ovidrel should not be used during pregnancy and lactation. For Ovidrel, no clinical data on exposed pregnancies are available. No reproduction studies with choriogonadotropin α in animals were performed. The potential risk for humans is unknown. There are no data on the excretion of choriogonadotropin α in milk.