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

Sponsor

Karadeniz Technical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02202278

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation Syndrome

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 Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital	Ankara		Turkey	06600

Sponsors and Collaborators

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