Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days (Gonapeptyl)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes|
- cost of treatment [ Time Frame: One month ] [ Designated as safety issue: No ]
- Implantation and pregnancy rates [ Time Frame: 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: GnRH agonist
Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
Triptorelin (0.1 mg, Gonapeptyl® Daily; Ferring, Kiel, Germany) in alternate-days from Day 1 of the menstrual cycle until the day of hCG administration.
Other Name: Gonapeptyl
Active Comparator: GnRH antagonist
Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.
When patients presented at least two follicles ≥ 14mm upon scan on days 7- 9, GnRH antagonist (cetrorelix, 0.25 mg/day, Cetrotide®; EMD Serono, Inc, Rockland, MA, USA) administration is started and continued until hCG administration.
Other Name: Cetrotide
Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.
No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468441
|Fertility - Assisted Fertilization Center|
|Sao Paulo, Brazil, 01401-002|
|Principal Investigator:||Luiz Guilherme Maldonado, M.Sc.||Fertility - Assisted Fertilization Center|