None listed
Conditions
Brief summary
Recombinant FSH and HMG (human menopausal gonadotropin) are commonly used in ovarian stimulation protocols. Several studies have evaluated the effectiveness of these two alternatives in IVF and reported conflicting results. The objective of this prospective randomized study is to analyze IVF outcomes of patients undergoing ovarian stimulation with FSH versus FSH-HMG for unexplained, tubal factor and mild male factor infertility.
Interventions
The long COH (controlled ovarian hyperstimulation) protocol is used in which the GnRH analogue (Leuprolide acetate )was administered in a dose of 1 mg/day subcutaneously starting in the mid-luteal phase of the preceding cycle (on the 21st day of preceding cycle). After down regulation (that is, pituitary desensitization) with leuprolide acetate; Arm 1 was stimulated only with subcutaneous recombinant FSH, the starting dose was between 150-450 IU depending on the patient's characteristics and the treatment was terminated when 2 or more follicules greater than 17mm in diameter was obtained; Arm 2 was stimulated with subcutaneous recombinant FSH and intramuscular HMG (human menopausal gonadotropin, 1 or 2 ampoules depending on the patient's characteristics) from the beginning and both drugs were continued till 2 or more follicules of 17mm in diameter was obtained; Arm 3 was stimulated with subcutaneous recombinant FSH and intramuscular HMG was added to the stimulation protocol when a 10 mm follicle developed and both drugs were continued till 2 or more follicules of 17mm in diameter was obtained
Sponsors
Study design
Eligibility
Inclusion criteria
mild male factor, tubal factor and unexplained infertility
Exclusion criteria
polycystic ovarian syndrome, poor responder patients (defined as having less than four follicles <15mm developed, or cycle cancellations in previous IVF attempts), previous fertilization failure (defined as fertilization rate less than 30% of the MII oocytes in a previous IVF cycle), any systemic, endocrine or metabolic illnesses, diminished ovarian reserve (defined as early follicular phase FSH>15 mIU/mL or AFC<5)