Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days (Gonapeptyl)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Triptorelin
Cetrorelix
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring ovarian stimulation, GnRH agonist, GnRH antagonist, hCG microdose, ICSI
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.
Sites / Locations
- Fertility - Assisted Fertilization Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GnRH agonist
GnRH antagonist
Arm Description
Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.
Outcomes
Primary Outcome Measures
cost of treatment
Secondary Outcome Measures
Implantation and pregnancy rates
Full Information
NCT ID
NCT01468441
First Posted
October 31, 2011
Last Updated
July 12, 2012
Sponsor
Fertility - Assisted Fertilization Center
1. Study Identification
Unique Protocol Identification Number
NCT01468441
Brief Title
Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days
Acronym
Gonapeptyl
Official Title
Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fertility - Assisted Fertilization Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ovarian stimulation, GnRH agonist, GnRH antagonist, hCG microdose, ICSI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GnRH agonist
Arm Type
Experimental
Arm Description
Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
Arm Title
GnRH antagonist
Arm Type
Active Comparator
Arm Description
Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Other Intervention Name(s)
Gonapeptyl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetrorelix
Other Intervention Name(s)
Cetrotide
Intervention Description
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.
Primary Outcome Measure Information:
Title
cost of treatment
Time Frame
One month
Secondary Outcome Measure Information:
Title
Implantation and pregnancy rates
Time Frame
2 months
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Guilherme Maldonado, M.Sc.
Organizational Affiliation
Fertility - Assisted Fertilization Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility - Assisted Fertilization Center
City
Sao Paulo
ZIP/Postal Code
01401-002
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23394779
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.
Results Reference
derived
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Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days
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