Ovarian Hyperstimulation SyndromeNCT02202278
Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients
An observational study of Ovarian Hyperstimulation Syndrome, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients that are administered luteal long protocol for controlled ovarian stimulation
Who may be able to join
- Patients in both groups are normoresponders or hyperresponders who will undergo assisted reproductive technology for male factor
Who cannot join
- known inherited or acquired thrombophilia
- previous thromboembolism
- previous, current or planned anti-thrombotic treatment
- first degree relatives with known genetic thrombophilia
- systemic diseases
- smoking.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital
Ankara, 06600
rafet duraker, MD, 905342325333, rafetduraker@gmail.com
yeşim bayoglu tekin, MD, 05055171973, yesimbay@yahoo.com
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- ovarian hyperstimulation, Oxidative Stress, IMA, OHSS, ICSI, long agonist protocol, TAC, TOS, OSI, MDA
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change the levels of oxidative stress markers
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, emine seda guvendag guven, Karadeniz Technical University
- Investigators
- emine seda guvendag guven, MD, Study director, Karadeniz Technical Universityrafet duraker, MD, Principal investigator, T. C Etlik Zubeyde Hanim Women's health Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202278
- Sponsor's protocol ID
- 139EK1
- Status last verified
- Jul 2014
- First submitted
- 23 Jul 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hitkari JA, Rowe TP, von Dadelszen P. Activated protein C and the ovarian hyperstimulation syndrome: possible therapeutic implications. Med Hypotheses. 2006;66(5):929-33. doi: 10.1016/j.mehy.2005.08.058. Epub 2006 Jan 24.
PubMed 16434147Westerlund E, Henriksson P, Wallen H, Hovatta O, Wallberg KR, Antovic A. Detection of a procoagulable state during controlled ovarian hyperstimulation for in vitro fertilization with global assays of haemostasis. Thromb Res. 2012 Oct;130(4):649-53. doi: 10.1016/j.thromres.2011.11.024. Epub 2011 Dec 7.
PubMed 22154245Agarwal A, Allamaneni SS. Role of free radicals in female reproductive diseases and assisted reproduction. Reprod Biomed Online. 2004 Sep;9(3):338-47. doi: 10.1016/s1472-6483(10)62151-7.
PubMed 15353087Velthut A, Zilmer M, Zilmer K, Kaart T, Karro H, Salumets A. Elevated blood plasma antioxidant status is favourable for achieving IVF/ICSI pregnancy. Reprod Biomed Online. 2013 Apr;26(4):345-52. doi: 10.1016/j.rbmo.2012.12.012. Epub 2013 Jan 16.
PubMed 23415995
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02202278
- Acronym / sponsor ID
- 139EK1
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- ovarian hyperstimulation, Oxidative Stress, IMA, OHSS, ICSI, long agonist protocol, TAC, TOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients that are administered luteal long protocol for controlled ovarian stimulation
Key inclusion criteria (1 listed)
- Patients in both groups are normoresponders or hyperresponders who will undergo assisted reproductive technology for male factor
Key exclusion criteria (6 listed)
- known inherited or acquired thrombophilia
- previous thromboembolism
- previous, current or planned anti-thrombotic treatment
- first degree relatives with known genetic thrombophilia
- systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Background: PubMed 16434147Hitkari JA, Rowe TP, von Dadelszen P. Activated protein C and the ovarian hyperstimulation syndrome: possible therapeutic implications. Med Hypotheses. 2006;66(5):929-33. doi: 10.1016/j.mehy.2005.08.058. Epub 2006 Jan 24.
- Background: PubMed 22154245Westerlund E, Henriksson P, Wallen H, Hovatta O, Wallberg KR, Antovic A. Detection of a procoagulable state during controlled ovarian hyperstimulation for in vitro fertilization with global assays of haemostasis. Thromb Res. 2012 Oct;130(4):649-53. doi: 10.1016/j.thromres.2011.11.024. Epub 2011 Dec 7.
- Background: PubMed 15353087Agarwal A, Allamaneni SS. Role of free radicals in female reproductive diseases and assisted reproduction. Reprod Biomed Online. 2004 Sep;9(3):338-47. doi: 10.1016/s1472-6483(10)62151-7.
- Background: PubMed 23415995Velthut A, Zilmer M, Zilmer K, Kaart T, Karro H, Salumets A. Elevated blood plasma antioxidant status is favourable for achieving IVF/ICSI pregnancy. Reprod Biomed Online. 2013 Apr;26(4):345-52. doi: 10.1016/j.rbmo.2012.12.012. Epub 2013 Jan 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emine seda guvendag guven, MD study director
Karadeniz Technical University
rafet duraker, MD principal investigator
T. C Etlik Zubeyde Hanim Women's health Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Hyperstimulation Syndrome, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emine seda guvendag guven, MD (905332339854, emineseda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the levels of oxidative stress markers (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202278, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.