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Step Up Versus Step Down in Controlled Ovarian Stimulation

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ClinicalTrials.gov Identifier: NCT01376999
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Miguel Angel Checa, Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
No Explained Sterility Drug: FSH-r (Follicule stimulate hormone) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Step Up Versus Step Down in Controlled Ovarian Stimulation for Intrauterine Insemination. A Controlled Randomised Trial.
Study Start Date : April 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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.
Drug: FSH-r (Follicule stimulate hormone)
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.
Drug: FSH-r (Follicule stimulate hormone)
Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r




Primary Outcome Measures :
  1. Ovulation rate [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with unexplained sterility with needs of intrauterine insemination.

Exclusion Criteria:

  • Contraindications to intrauterine insemination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376999


Locations
Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar

Responsible Party: Miguel Angel Checa, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01376999     History of Changes
Other Study ID Numbers: UREP-01-2009
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Miguel Angel Checa, Parc de Salut Mar:
Sterility
FSH-r
intrauterine insemination
unexplained sterility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs