Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days
NCT ID: NCT01468441
Last Updated: 2012-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2011-09-30
2012-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GnRH agonist
Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
Triptorelin
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.
GnRH antagonist
Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.
Cetrorelix
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.
Interventions
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Triptorelin
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.
Cetrorelix
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
35 Years
FEMALE
No
Sponsors
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Fertility - Assisted Fertilization Center
OTHER
Responsible Party
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Principal Investigators
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Luiz Guilherme Maldonado, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Fertility - Assisted Fertilization Center
Locations
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Fertility - Assisted Fertilization Center
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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Fert-LG-Doutorado
Identifier Type: -
Identifier Source: org_study_id