Step Up Versus Step Down in Controlled Ovarian Stimulation
This study is currently recruiting participants.
Verified February 2013 by Parc de Salut Mar
Sponsor:
Parc de Salut Mar
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013