- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037699
Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles
Study Overview
Status
Conditions
Detailed Description
All patients received an oral contraceptive pill with 0.030 mg of ethinyl-estradiol and 3.0 mg of drospirenone the cycle prior to ovarian stimulation. On the second day of menstruation, patients started ovarian stimulation as follows:
Patients < 36: 225 IU/day of recombinant FSH (FSH alone group) or 150 IU of rFSH and 75 IU of rLH/day (FSH+LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration.
Patients 36-39: Initial dose of 300 IU of rFSH /day (FSH alone group)) or 225 IU of rFSH and 75 IU of rLH/day (FSH + LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration.
A maximum of 3 embryos were transferred on day 3 of embryo development.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Valencia, Spain, 46117
- IVI Valencia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1st-2nd IVF cycle.
- Age until 39 years old
- BMI: 18-29.9.
- Basal FSH < 12 IU/L
Exclusion Criteria:
- LH:FSH > 2 (PCO)
- Low response background (< 5 oocytes)
- Endometrioma
- Recurrent pregnancy loss
- Any preimplantational genetic diagnosis indication
- Any systemic, metabolic or endocrinological disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: FSH YOUNGER
|
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Active Comparator: FSH OLDER
|
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Experimental: FSH LH YOUNGER (Recombinant Luteotrophin alfa)
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Experimental: FSH LH OLDER
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Implantation rate
Time Frame: 4 weeks after embryo transfer
|
4 weeks after embryo transfer
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ernesto Bosch, MDPhD, IVI Valencia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0502-C-M05-EB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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