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CompletedNCT04371991Updated May 5, 2020

Kisspeptin Levels in Early Pregnancy

An observational study in Early Pregnancy and Ectopic Pregnancy, sponsored by Semra Yuksel. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-05.

Sponsored by Semra Yuksel · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
88
Ages
18 Years to 37 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Pregnancy, Ectopic with a site in Turkey — 2 open to participants now, 2 under way, none of them phase 3. Pregnancy, Ectopic · Turkey.

Started
2019
the only one that year
Observational
7 of 13
1 open now
Registered
8th of 13
by date
Lead sponsor
1 of 13
Semra Yuksel

Among the 13 studies in Pregnancy, Ectopic with a site in Turkey, this one is the only one that started in 2019, is one of 7 observational ones, and was the 8th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

Observationalthis study7 · 1 open
No phase6 · 1 open

By the year they started

First in 2012; this study’s year is marked. 1 started in 2019.

What they test

Size and results

Median enrollment 73 across the 6 interventional studies, 85 across the 7 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Pregnancy, Ectopic with a site in Turkey, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Early Pregnancy
  • Ectopic Pregnancy

Browse trials for

Keywords

  • kisspeptin
  • ectopic pregnancy
04

Who can participate

Ages eligible
18 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Women aged between 18-37 years presented with between 5-6 weeks of gestation by last menstrual period.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
88 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group 1

    Ectopic pregnancy

    Diagnostic Test: blood test

  • Group 2

    Early viable pregnancy

    Diagnostic Test: blood test

  • Group 3

    incomplete miscarriage

    Diagnostic Test: blood test

  • Group 4

    Healthy women

    Diagnostic Test: blood test

Interventions

  • Diagnostic testblood test

    blood test (serum samples) for biochemical examination

06

What researchers measure

Primary outcomes

  1. Kisspeptin levels in early pregnancy

    Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.

    Time frame: January 2019-January 2020

07

Study locations

1 site
  • Gaziosmanpasa Taksim Education and Research Hospital
    Istanbul, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Aug 2019, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2020
First posted
May 1, 2020
StartActual
Jan 5, 2019
Primary completionActual
Aug 1, 2019
CompletionActual
Nov 5, 2019
Last update
May 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04371991
Lead sponsor
Semra Yuksel
Responsible party
Semra Yuksel (Principal investigator, MD, Gaziosmanpasa Research and Education Hospital) — Sponsor-investigator
First posted
May 1, 2020
Start date
Jan 5, 2019
Primary completion
Aug 1, 2019
Completion
Nov 5, 2019
Last update
May 5, 2020

Study contacts

sibel bektas, proffessor
study chair · Gaziosmanpasa Taksim Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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