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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: ascorbate 1000mg, vitamin E 400, zinc and selenium

• Registration Number: NCT02058212
• Lead Sponsor: Cairo University

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 .

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-07
• Last Update Submitted: 2014-02-07
• Study First Posted: 2014-02-10
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• patients with endometriosis

Exclusion Criteria

patients with no endometriosis , not suitable for ICSI-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no antioxidant , ROS , pregnancy outcome	ascorbate 1000mg, vitamin E 400, zinc and selenium	no 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	ascorbate 1000mg, vitamin E 400, zinc and selenium	anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	2 months	long protocol administration

Trial Locations

Locations (1)

egyption centre for IVF; 🇪🇬 Maadi, Egypt