Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)
ROS
Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome
1 other identifier
interventional
50
1 country
3
Brief Summary
ROS plays an essential role in the pathogenesis of many reproductive processes. High follicular fluid ROS levels are associated with negative IVF outcomes. is plasma level of reactive oxygen species is affected by antioxidant treatment in endometriotic women?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2013
Shorter than P25 for phase_2
3 active sites
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
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 10, 2014
CompletedFebruary 10, 2014
February 1, 2014
7 months
February 5, 2014
February 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma reactive oxygen species affection by antioxidant treatment
measure before and 3months after antioxidant treatment
3 months
Secondary Outcomes (1)
clinical pregnancy rate
2 months
Study Arms (2)
no antioxidant , ROS , pregnancy outcome
PLACEBO COMPARATORno anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) will be given to endometriotic women undergoing IVF
antioxidant , ROS , pregnancy outcome
ACTIVE COMPARATORanti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)
Interventions
anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) are given to half patients only before IVF , plasma level of ROS are detected before and on day of oocyte retrieval then correlated to pregnancy outcome
Eligibility Criteria
You may qualify if:
- patients with endometriosis
You may not qualify if:
- patients with no endometriosis , not suitable for ICSI-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (3)
egyption centre for IVF
Maadi, 11451, Egypt
Unknown Facility
Maadi, 11451, Egypt
Unknown Facility
Maadi, 1, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
olfat nouh riad, MD
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisstant professor
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 10, 2014
Study Start
March 1, 2013
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
February 10, 2014
Record last verified: 2014-02