Step Up Versus Step Down in Controlled Ovarian Stimulation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01376999
First received: June 17, 2011
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
No Explained Sterility
Drug: FSH-r (Follicule stimulate hormone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Step Up Versus Step Down in Controlled Ovarian Stimulation for Intrauterine Insemination. A Controlled Randomised Trial.

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Ovulation rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 158
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376999

Contacts
Contact: Miguel A. PhD Checa, PhD 0034 93 248 31 29 macheca@parcdesalutmar.cat
Contact: Ana B. Md Robles, Md 003493 248 31 29 arobles@parcdesalutmar.cat

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Miguel Angel PhD Checa, PhD    003493 248 31 29    macheca@parcdesalutmar.cat   
Principal Investigator: Miguel Angel PhD Checa, PhD         
Sponsors and Collaborators
Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01376999     History of Changes
Other Study ID Numbers: UREP-01-2009
Study First Received: June 17, 2011
Last Updated: February 14, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 28, 2014