Step Up Versus Step Down in Controlled Ovarian Stimulation
September 19, 2017 updated by: Miguel Angel Checa, Parc de Salut Mar
Step Up Versus Step Down in Controlled Ovarian Stimulation for Intrauterine Insemination. A Controlled Randomised Trial.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
158
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 37 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women with unexplained sterility with needs of intrauterine insemination.
Exclusion Criteria:
- Contraindications to intrauterine insemination.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Step Down
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: 75 IU FSH-r Step-Down: 150 FSH-r
|
|
Active Comparator: Step Up
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.
|
Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ovulation rate
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
June 17, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (Estimate)
June 20, 2011
Study Record Updates
Last Update Posted (Actual)
September 20, 2017
Last Update Submitted That Met QC Criteria
September 19, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UREP-01-2009
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.