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Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI) (ROS)

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
ascorbate 1000mg, vitamin E 400, zinc and selenium
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis focused on measuring ICSI, antioxidants, ROS, endometriosis

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with endometriosis

Exclusion Criteria:

patients with no endometriosis , not suitable for ICSI-

Sites / Locations

  • egyption centre for IVF

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

no antioxidant , ROS , pregnancy outcome

antioxidant , ROS , pregnancy outcome

Arm Description

no anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) will be given to endometriotic women undergoing IVF

anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)

Outcomes

Primary Outcome Measures

plasma reactive oxygen species affection by antioxidant treatment
measure before and 3months after antioxidant treatment

Secondary Outcome Measures

clinical pregnancy rate
long protocol administration

Full Information

First Posted
February 5, 2014
Last Updated
February 7, 2014
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02058212
Brief Title
Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)
Acronym
ROS
Official Title
Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?
Detailed Description
Study design, size, duration: : prospective randomized controlled clinical trial 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . randomization was done by closed envelop single blind for patient Participants/materials, setting, methods: was done in the Egyptian centre for IVF from March 2013 to October 2013 . 50 patients with endometriosis diagnosed by US prepared for ICSI were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . all patients were subjected to plasma sample before start long protocol for induction and second on day of ovum pick up . embryo transfer was done according to embryo grading .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
ICSI, antioxidants, ROS, endometriosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no antioxidant , ROS , pregnancy outcome
Arm Type
Placebo Comparator
Arm Description
no anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) will be given to endometriotic women undergoing IVF
Arm Title
antioxidant , ROS , pregnancy outcome
Arm Type
Active Comparator
Arm Description
anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)
Intervention Type
Drug
Intervention Name(s)
ascorbate 1000mg, vitamin E 400, zinc and selenium
Intervention Description
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
Primary Outcome Measure Information:
Title
plasma reactive oxygen species affection by antioxidant treatment
Description
measure before and 3months after antioxidant treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
long protocol administration
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with endometriosis Exclusion Criteria: patients with no endometriosis , not suitable for ICSI-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
olfat nouh riad, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
egyption centre for IVF
City
Maadi
ZIP/Postal Code
11451
Country
Egypt
City
Maadi
ZIP/Postal Code
11451
Country
Egypt
City
Maadi
ZIP/Postal Code
1
Country
Egypt

12. IPD Sharing Statement

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Use of Antioxidant in Endometriotic Women to Improve Intracytoplasmic Sperm Injection (ICSI)

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