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

July 24, 2014 updated by: emine seda guvendag guven, Karadeniz Technical University

Serum Levels of IMA, TAC, TOS, OSI and MDA in Severe OHSS Patients Underwent Long Agonist Protocol Intracytoplasmic Sperm for Determining Oxidative Stress Status

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06600
        • Recruiting
        • T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Serdar Dilbaz, MD
        • Sub-Investigator:
          • Ahmet Mentese, MD
        • Sub-Investigator:
          • Sevim Aydin, MD

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

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients that are administered luteal long protocol for controlled ovarian stimulation

Description

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 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

Cohorts and Interventions

Group / Cohort
ovarian hyperstimulation patients
Moderate OHSS is defined as abdominal distension and discomfort, nausea with or without vomiting, ovarian enlargement (ovarian size of 8-12 cm) and ascites that revealed by ultrasonografic examination. Severe OHSS criteria is defined as ovarian enlargement, ascites with or without hydrothorax, haematocrit >45%, weight gain >2 kg, white blood cell count >15.000, oliguria, creatinine of 1.0-1.5, creatinine clearance of >50 ml/min, liver dysfunction.
without ovarian hiperstimulation
Control group is composed of patients who underwent long luteal protocol but do not demonstrate symptoms of OHSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change the levels of oxidative stress markers
Time Frame: 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
1 day

Collaborators and Investigators

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

Sponsor

Karadeniz Technical University

Investigators

  • Study Director: emine seda guvendag guven, MD, Karadeniz Technical University
  • Principal Investigator: rafet duraker, MD, T. C Etlik Zubeyde Hanim Women's health Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 139EK1

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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