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

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with endometriosis Exclusion Criteria: patients with no endometriosis , not suitable for ICSI-

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: no antioxidant , ROS , pregnancy outcome<br>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<br>* 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<br>|
| Active Comparator: antioxidant , ROS , pregnancy outcome<br>anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) | Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICSI, antioxidants, ROS, endometriosis