Clinical trial NCT01468441: Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days
Official title: Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: ovarian stimulation
GnRH agonist
GnRH antagonist
hCG microdose
ICSI
Lead sponsor: Fertility - Assisted Fertilization Center
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 96
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* women of good physical and mental health
* under 37 years old, with regular menstrual cycles of 25-35 days
* normal basal FSH and LH levels
* 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
* all patients signed a written informed consent form
* no patient had received any hormone therapy for at least 60 days preceding the study.

Primary outcomes:
measure: cost of treatment
timeFrame: One month
Secondary outcomes:
measure: Implantation and pregnancy rates
timeFrame: 2 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Fertility - Assisted Fertilization Center
Study officials:
affiliation: Fertility - Assisted Fertilization Center
name: Luiz Guilherme Maldonado, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maldonado LG, Franco JG Jr, Setti AS, Iaconelli A Jr, Borges E Jr. Cost-effectiveness comparison between pituitary down-regulation with a gonadotropin-releasing hormone agonist short regimen on alternate days and an antagonist protocol for assisted fertilization treatments. Fertil Steril. 2013 May;99(6):1615-22. doi: 10.1016/j.fertnstert.2013.01.095. Epub 2013 Feb 5.