Early PregnancyNCT04371991
Kisspeptin Levels in Early Pregnancy
An observational study of Early Pregnancy and Ectopic Pregnancy, run by Semra Yuksel at 1 site in Turkey (Türkiye).
Trial summary
Kisspeptins are a family of neuropeptides that are critical for the puberty initiation and female fertility. The investigators aimed to investigate in this study kisspeptin levels in early pregnancy, ectopic pregnancy, and early pregnancy loss. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy, Ectopic Pregnancy
- What is being tested?
- blood test
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2019to 5 Nov 2019
- How long will I take part?
- 6 Months
- 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 37 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women were considered for the study if they presented between 5-6 weeks of gestation by last menstrual period. Patients were included if they had either confirmed intrauterine pregnancy (IUP) by ultrasound (n=22) or confirmed miscarriage (SAB) by ultrasound (n=20) or ectopic pregnancy.
Who may be able to join
- Women aged between 18-37 years presented with between 5-6 weeks of gestation by last menstrual period.
Who cannot join
- Women older than 37 years or younger than 18 years
- Women with a molar pregnancy, multiple gestations, gestational age past 6 weeks at the time of blood draw, or if pregnancies were assisted conceptions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Taksim Education and Research Hospital
Istanbul
About this study
Official title: Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?
Kisspeptins are a family of neuropeptides that are critical for the puberty initiation and female fertility. The investigators aimed to investigate in this study kisspeptin levels in early pregnancy, ectopic pregnancy, and early pregnancy loss.
Read the detailed description
Clinicians can easily do a differential diagnosis of early pregnancy, miscarriage, and ectopic pregnancy when the human chorionic gonadotropin (hCG) values higher than 2000 mIU/mL with transvaginal ultrasound. However, in cases where the hCG value is below the critical threshold of 1500 to 2000 mIU/mL (often called the discrimination level) and ultrasound is not likely to be diagnostic, the pregnancy is of unknown location. Plasma or serum kisspeptin is mainly derived from the placenta during pregnancy and plasma kisspeptin levels significantly increase across pregnancy. Plasma kisspeptin levels could be used as a potential biomarker for the discrimination of miscarriage and ectopic pregnancy.
All statistics will be carried out with the use of SPSS (ver. 21, IBM). A P value of <.05 is considered to be statistically significant. Pearson chi-square test will be used to evaluate between-group differences by pregnancy outcome for categoric data. Kisspeptin differences will be calculated between groups with one way ANOVA.
- Conditions
- Early Pregnancy, Ectopic Pregnancy
- Being tested
- blood test
- Keywords
- kisspeptin, ectopic pregnancy
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
blood test (serum samples) for biochemical examination
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Ectopic pregnancy Receives: Diagnostic Test: blood test | |
| Group 2 | Early viable pregnancy Receives: Diagnostic Test: blood test | |
| Group 3 | incomplete miscarriage Receives: Diagnostic Test: blood test | |
| Group 4 | Healthy women Receives: Diagnostic Test: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kisspeptin levels in early pregnancy
Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.
Measured: January 2019-January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start5 Jan 2019
- Primary completion1 Aug 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Cross-sectional
- Enrolment
- 88 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Semra Yuksel
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Semra Yuksel, Gaziosmanpasa Research and Education Hospital
- Investigators
- sibel bektas, proffessor, Study chair, Gaziosmanpasa Taksim Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371991
- Sponsor's protocol ID
- GaziosmanpasaTREH20
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?
- ClinicalTrials.gov ID
- NCT04371991
- Acronym / sponsor ID
- GaziosmanpasaTREH20
- Conditions
- Early Pregnancy, Ectopic Pregnancy
- Keywords
- kisspeptin, ectopic pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Semra YukselOther government
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 1 May 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.
Kisspeptins are a family of neuropeptides that are critical for the puberty initiation and female fertility. The investigators aimed to investigate in this study kisspeptin levels in early pregnancy, ectopic pregnancy, and early pregnancy loss.
Detailed description
Clinicians can easily do a differential diagnosis of early pregnancy, miscarriage, and ectopic pregnancy when the human chorionic gonadotropin (hCG) values higher than 2000 mIU/mL with transvaginal ultrasound. However, in cases where the hCG value is below the critical threshold of 1500 to 2000 mIU/mL (often called the discrimination level) and ultrasound is not likely to be diagnostic, the pregnancy is of unknown location. Plasma or serum kisspeptin is mainly derived from the placenta during pregnancy and plasma kisspeptin levels significantly increase across pregnancy. Plasma kisspeptin levels could be used as a potential biomarker for the discrimination of miscarriage and ectopic pregnancy.
All statistics will be carried out with the use of SPSS (ver. 21, IBM). A P value of <.05 is considered to be statistically significant. Pearson chi-square test will be used to evaluate between-group differences by pregnancy outcome for categoric data. Kisspeptin differences will be calculated between groups with one way ANOVA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: blood testEctopic pregnancy |
| Group 2 | – | Diagnostic Test: blood testEarly viable pregnancy |
| Group 3 | – | Diagnostic Test: blood testincomplete miscarriage |
| Group 4 | – | Diagnostic Test: blood testHealthy women |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women were considered for the study if they presented between 5-6 weeks of gestation by last menstrual period. Patients were included if they had either confirmed intrauterine pregnancy (IUP) by ultrasound (n=22) or confirmed miscarriage (SAB) by ultrasound (n=20) or ectopic pregnancy.
Key inclusion criteria (1 listed)
- Women aged between 18-37 years presented with between 5-6 weeks of gestation by last menstrual period.
Key exclusion criteria (2 listed)
- Women older than 37 years or younger than 18 years
- Women with a molar pregnancy, multiple gestations, gestational age past 6 weeks at the time of blood draw, or if pregnancies were assisted conceptions
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 |
|---|---|---|
| blood testblood test (serum samples) for biochemical examination | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Kisspeptin levels in early pregnancy
Time frame: January 2019-January 2020
Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.
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 5 May 2020.
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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.
sibel bektas, proffessor study chair
Gaziosmanpasa Taksim Education and Research 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 Early Pregnancy and Ectopic Pregnancy, run by Semra Yuksel 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 5 May 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?
Kisspeptin levels in early pregnancy (time frame: January 2019-January 2020). 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 5 May 2020.