Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients

• Conditions: Ovarian Hyperstimulation Syndrome

• Registration Number: NCT02202278
• Lead Sponsor: Karadeniz Technical University

Brief Summary

The aim of the study is to determine serum oxidative stress status by ischemia modified albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control group. We also aim to reveal the association between serum levels of these factors and oocyte quality.

Detailed Description

* Patients included in this study were assisted reproductive technique (ART) patients with moderate and severe OHSS who were hospitalized for management

* Control patients are selected from patients without signs of OHSS

* All patients are administered luteal long protocol for controlled ovarian stimulation. Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin, Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the second or third day of menstruation.

* When there are at least two or three follicles \>17 mm in diameter, recombinant human chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied subcutaneously 34-36 hours before oocyte retrieval.

* Serum samples are collected on day of HCG for study and control group patients.

* Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels.

* This is a case control study

* Statistical analyses will be performed using student t-test and fisher chi-square test. The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined in all study groups using Spearman correlation analysis.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-24
• Last Update Submitted: 2014-07-24
• Study First Posted: 2014-07-29
• Last Update Posted: 2014-07-29
• Primary Completion: 2014-09
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Patients in both groups are normoresponders or hyperresponders who will undergo assisted reproductive technology for male factor

Exclusion Criteria

• known inherited or acquired thrombophilia
• previous thromboembolism
• previous, current or planned anti-thrombotic treatment
• first degree relatives with known genetic thrombophilia
• systemic diseases
• smoking.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change the levels of oxidative stress markers	1 day	Serum will be obtained for studiying ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels

Trial Locations

Locations (1)

T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital; 🇹🇷 Ankara, Turkey