Back to resultsStep Up Versus Step Down in Controlled Ovarian Stimulation
Primary Purpose
No Explained Sterility
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
FSH-r (Follicule stimulate hormone)
Sponsored by
About this trial
This is an interventional treatment trial for No Explained Sterility focused on measuring Sterility, FSH-r, intrauterine insemination, unexplained sterility
Eligibility Criteria
Inclusion Criteria:
- Women with unexplained sterility with needs of intrauterine insemination.
Exclusion Criteria:
- Contraindications to intrauterine insemination.
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Step Down
Step Up
Arm Description
Step Down: We begin the COS (controlled ovarian stimulation) with 150 IU of FSH-r until 7th day of stimulation. This day we make an adjustment reducing the dose if necessary.
Step up: We begin the COS (controlled ovarian stimulation) with 75 IU of FSH-r until 7th day of stimulation.This day we make an adjustment increasing the dose if necessary.
Outcomes
Primary Outcome Measures
Ovulation rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01376999
Brief Title
Step Up Versus Step Down in Controlled Ovarian Stimulation
Official Title
Step Up Versus Step Down in Controlled Ovarian Stimulation for Intrauterine Insemination. A Controlled Randomised Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
No Explained Sterility
Keywords
Sterility, FSH-r, intrauterine insemination, unexplained sterility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Step Down
Arm Type
Experimental
Arm Description
Step Down: We begin the COS (controlled ovarian stimulation) with 150 IU of FSH-r until 7th day of stimulation. This day we make an adjustment reducing the dose if necessary.
Arm Title
Step Up
Arm Type
Active Comparator
Arm Description
Step up: We begin the COS (controlled ovarian stimulation) with 75 IU of FSH-r until 7th day of stimulation.This day we make an adjustment increasing the dose if necessary.
Intervention Type
Drug
Intervention Name(s)
FSH-r (Follicule stimulate hormone)
Intervention Description
Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r
Primary Outcome Measure Information:
Title
Ovulation rate
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with unexplained sterility with needs of intrauterine insemination.
Exclusion Criteria:
Contraindications to intrauterine insemination.
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
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Step Up Versus Step Down in Controlled Ovarian Stimulation
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