Recurrent Pregnancy Loss Without Current PregnancyNCT01735331
Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss
An observational study of Recurrent Pregnancy Loss Without Current Pregnancy, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is determine vascular endothelial growth factor levels and angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels will be measured by immunohistochemical staining methods… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss Without Current Pregnancy
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2012to Aug 2013
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The patients with Recurrent Pregnancy Loss
Who may be able to join
- Patients with Recurrent Pregnancy Loss who accept to join the study.
Who cannot join
- Patients whose age of <18 and >45
- Patients with have any pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul
About this study
The aim of this study is determine vascular endothelial growth factor levels and angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels will be measured by immunohistochemical staining methods due to office hysteroscopic endometrial biopsy after the menstruation at follicular phase of menstrual cycle.
Read the detailed description
This study is a prospective,observational,single-center study.Ethical approval was obtained from the Institutional Review Board.This study will be completed 30 patients with Habitual Abortus.
Endometrial vascular endothelial growth factor levels will be measured using Flk-1 / Kinase Domain Receptor / Vascular endothelial growth factor receptor-2, Ab-1 (Rabbit PAb), Vascular Endothelial Growth Factor (VEGF) Ab-7 (VG1), Cluster of Differentiation 34 (Endothelial Cell Marker) Ab-1 (QBEnd/10), Vascular endothelial growth factor receptor-1 (N-term) (FLT1) antibody kits. All assays will be performed according to the manufacturer's instructions.
- Keywords
- Vascular endothelial growth factor, Recurrent Pregnancy Loss
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 |
|---|---|---|
| VEGF level | VEGF level in hysteroscopic endometrial biopsy of the patients with recurrent pregnancy loss. | |
| control group | Patients with Abnormal Uterine Bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study is to determine endometrial vascular endothelial growth factor levels in patient with Recurrent Pregnancy Loss
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy Loss Without Current PregnancyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- TANER A. USTA, M.D., Principal investigator, Bagcilar Training and Research Hospital,Istanbul,Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735331
- Sponsor's protocol ID
- BEHGynObs-3
- Status last verified
- Aug 2015
- First submitted
- 26 Nov 2012
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Endothelial Growth Factor Levels at Hysteroscopic Biopsies Which Taken From Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT01735331
- Acronym / sponsor ID
- BEHGynObs-3
- Keywords
- Vascular endothelial growth factor, Recurrent Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Nov 2012 (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 this study is determine vascular endothelial growth factor levels and angiogenesis/vascularity from hysteroscopic endometrial biopsies which taken from patients who has Recurrent Pregnancy Loss.The endometrial vascular endothelial growth factor levels will be measured by immunohistochemical staining methods due to office hysteroscopic endometrial biopsy after the menstruation at follicular phase of menstrual cycle.
Detailed description
This study is a prospective,observational,single-center study.Ethical approval was obtained from the Institutional Review Board.This study will be completed 30 patients with Habitual Abortus.
Endometrial vascular endothelial growth factor levels will be measured using Flk-1 / Kinase Domain Receptor / Vascular endothelial growth factor receptor-2, Ab-1 (Rabbit PAb), Vascular Endothelial Growth Factor (VEGF) Ab-7 (VG1), Cluster of Differentiation 34 (Endothelial Cell Marker) Ab-1 (QBEnd/10), Vascular endothelial growth factor receptor-1 (N-term) (FLT1) antibody kits. All assays will be performed according to the manufacturer's instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEGF level | – | –VEGF level in hysteroscopic endometrial biopsy of the patients with recurrent pregnancy loss. |
| control group | – | –Patients with Abnormal Uterine Bleeding |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients with Recurrent Pregnancy Loss
Key inclusion criteria (1 listed)
- Patients with Recurrent Pregnancy Loss who accept to join the study.
Key exclusion criteria (2 listed)
- Patients whose age of <18 and >45
- Patients with have any pregnancy.
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
The primary outcome measure of this study is to determine endometrial vascular endothelial growth factor levels in patient with Recurrent Pregnancy Loss
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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.
TANER A. USTA, M.D. principal investigator
Bagcilar Training and Research Hospital,Istanbul,Turkey.
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 Recurrent Pregnancy Loss Without Current Pregnancy, run by Bagcilar Training and Research Hospital 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 2 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: finished, as of the sponsor's last update on 7 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure of this study is to determine endometrial vascular endothelial growth factor levels in patient with Recurrent Pregnancy Loss (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.