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

February 7, 2014 updated by: olfat nouh riad, Cairo University

Does Antioxidant Supplementation to Endometriotic Women Undergoing ICSI Could Alter Reactive Oxygen Species (ROS) Levels and Affect Pregnancy Outcome

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Maadi, Egypt, 11451
        • egyption centre for IVF
      • Maadi, Egypt, 11451
      • Maadi, Egypt, 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients with endometriosis

Exclusion Criteria:

patients with no endometriosis , not suitable for ICSI-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: no antioxidant , ROS , pregnancy outcome
no anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) will be given to endometriotic women undergoing IVF
Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium
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
ACTIVE_COMPARATOR: antioxidant , ROS , pregnancy outcome
anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)
Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma reactive oxygen species affection by antioxidant treatment
Time Frame: 3 months
measure before and 3months after antioxidant treatment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 2 months
long protocol administration
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: olfat nouh riad, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (ESTIMATE)

February 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • antioxidants for endometriosis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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