Supplementation With Human Chorionic Gonadotropin (hCG) During Controlled Ovarian Stimulation With Recombinant Follicle-stimulating Hormone (FSH) for In Vitro Fertilisation

Inclusion criteria

• Females with indication for COS and IVF;
• Age between 25-37 years;
• BMI >18 and < 30 kg/m2;
• A regular menstrual cycle between 24 and 35 days and presumed to be ovulatory;
• Two ovaries;
• Tubal or unexplained infertility, including endometriosis stage I/II;
• A uterus consistent with expected normal function (e.g. no clinically interfering uterine fibroids) documented by transvaginal ultrasound at the screening;
• Male partner with sperm quality compatible with fertilization via IVF procedure or previous clinical pregnancy;
• Early follicular phase serum FSH levels of 1-12 IU/l;
• Early follicular phase total antral follicle (2-10mm) count ≥ 6;
• Confirmation of down-regulation before randomisation by transvaginal ultrasound;
• Willing and able to sign informed consent.

Exclusion criteria

• History of or current PCOS, endometriosis stage III/IV or severe male factor requiring ICSI;
• History of severe ovarian hyperstimulation syndrome (OHSS);
• Presence of unilateral or bilateral hydrosalpinx at ultrasound;
• More than three previously COS cycles;
• Previous poor response on an IVF-cycle, defined as >20 days of gonadotrophin stimulation, cancellation due to limited follicular response or less than four follicles of ³15 mm diameter;
• Previous IVF cycle with unsuccessful fertilization, defined as fertilisation of £20% of the retrieved oocytes;
• History of recurrent miscarriage;
• FSH>12IU/L or LH>12UI/L (early follicular phase);
• Contraindications for the use of gonadotropins or GnRH analogues;
• Recent history of current epilepsy, HIV infection, diabetes or cardiovascular gastrointestinal, hepatic, renal or pulmonary disease;
• Pregnancy, lactation or contraindication to pregnancy;
• Current past (last 12 months) abuse of alcohol or drugs;
• History of chemotherapy (except for gestational conditions) of radiotherapy;
• Undiagnosed vaginal bleeding;
• Tumours of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy;
• Abnormal karyotyping of the patient (if karyotyping is performed);
• Hypersensitivity to any trial product.