Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to investigate the efficacy and safety of cabergoline in prevention of ovarian hyperstimulation syndrome versus albumin in ART program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMay 6, 2015
November 1, 2009
4 years
November 5, 2009
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage and severity of OHSS in two groups
6 days after embryos transfer (ET)
Secondary Outcomes (1)
Efficacy and safety of cabergoline and albumin
6 days after embryos transfer (ET)
Study Arms (2)
Control
SHAM COMPARATORReceive human albumin 20% infusion
Cabergoline
EXPERIMENTALReceive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
Interventions
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
Eligibility Criteria
You may qualify if:
- patients at risk of developing OHSS, defined by the development of 20-30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes
- ovarian stimulation with long protocol
You may not qualify if:
- coasting cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR
Tehran, Tehran Province, 14114, Iran
Related Publications (1)
Tehraninejad ES, Hafezi M, Arabipoor A, Aziminekoo E, Chehrazi M, Bahmanabadi A. Comparison of cabergoline and intravenous albumin in the prevention of ovarian hyperstimulation syndrome: a randomized clinical trial. J Assist Reprod Genet. 2012 Mar;29(3):259-64. doi: 10.1007/s10815-011-9708-4. Epub 2012 Jan 10.
PMID: 22231013DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eniseh Tehraninejad, MD
Royan Institute
- STUDY DIRECTOR
Ashraf Moini, MD
Board scientific
- PRINCIPAL INVESTIGATOR
Marzieh Shiva, MD
scientist
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2013
Study Completion
July 1, 2013
Last Updated
May 6, 2015
Record last verified: 2009-11