Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients
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|ClinicalTrials.gov Identifier: NCT02202278|
Recruitment Status : Unknown
Verified July 2014 by emine seda guvendag guven, Karadeniz Technical University.
Recruitment status was: Recruiting
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
|Condition or disease|
|Ovarian Hyperstimulation Syndrome|
- 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|
|Estimated Enrollment :||25 participants|
|Observational Model:||Case Control|
|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 :||June 2014|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||October 2014|
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
- 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
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202278
|Contact: emine seda guvendag guven, MDemail@example.com|
|Contact: suleyman guven, MDfirstname.lastname@example.org|
|T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital||Recruiting|
|Ankara, Turkey, 06600|
|Contact: rafet duraker, MD 905342325333 email@example.com|
|Contact: yeşim bayoglu tekin, MD 05055171973 firstname.lastname@example.org|
|Sub-Investigator: Serdar Dilbaz, MD|
|Sub-Investigator: Ahmet Mentese, MD|
|Sub-Investigator: Sevim Aydin, MD|
|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|