Recurrent Pregnancy LossNCT04455256
Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss
An observational study of Recurrent Pregnancy Loss and Endoplasmic Reticulum Stress, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pregnancy Loss, Endoplasmic Reticulum Stress
- What is being tested?
- x box binding protein
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 7 Jul 2020
- 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
- Healthy volunteers accepted
- Adult
Study population: Loss of 3 or more pregnancy between the ages of 18 and 45 and women who have given at least 1 healthy birth in the same age group.
Who may be able to join
- with three or more miscarriages before 20 th week of gestation
- had no chronic or acute inflammatory disease
- used no steroids, anti-inflammatory, or antioxidant medications
Who cannot join
- had inflammatory diseases
- had systemic disease
- Anatomical abnormalities, infectious, endocrine, or genetic etiologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss
To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.
- Being tested
- x box binding protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x box binding proteinOther
Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.
| Study group | Role | What they receive |
|---|---|---|
| recurrent pregnancy loss group | Women between the ages of 18 and 45 who had a history of miscarriage under 3 weeks and above 22 weeks were included in this group. Receives: Other: x box binding protein | |
| women who had healthy birth | Women between the ages of 18-45 who have not had a history of pregnancy loss and who have had at least one healthy birth and no known chronic diseases are included in this group. Receives: Other: x box binding protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss
Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.
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 posted2 Jul 2020
- Study start20 Mar 2020
- Primary completion1 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455256
- Sponsor's protocol ID
- tgk-xbp
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoplasmic Reticulum Stress in Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT04455256
- Acronym / sponsor ID
- tgk-xbp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 2 Jul 2020 (actual)
- 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.
To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recurrent pregnancy loss group | – | Other: x box binding proteinWomen between the ages of 18 and 45 who had a history of miscarriage under 3 weeks and above 22 weeks were included in this group. |
| women who had healthy birth | – | Other: x box binding proteinWomen between the ages of 18-45 who have not had a history of pregnancy loss and who have had at least one healthy birth and no known chronic diseases are included in this group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Loss of 3 or more pregnancy between the ages of 18 and 45 and women who have given at least 1 healthy birth in the same age group.
Key inclusion criteria (3 listed)
- with three or more miscarriages before 20 th week of gestation
- had no chronic or acute inflammatory disease
- used no steroids, anti-inflammatory, or antioxidant medications
Key exclusion criteria (3 listed)
- had inflammatory diseases
- had systemic disease
- Anatomical abnormalities, infectious, endocrine, or genetic etiologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| x box binding proteinSerum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured. | Other | recurrent pregnancy loss group, women who had healthy birth |
Primary outcome
Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss
Time frame: 3 months
Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.
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 16 Jul 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Endoplasmic Reticulum Stress, run by Kanuni Sultan Suleyman 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 3 inclusion and 3 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 16 Jul 2020. 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?
Show the effect of endoplasmic reticulum stress on 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 16 Jul 2020.