Kisspeptin Levels in Early Pregnancy

Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04371991

Enrollment

Registered

2020-05-01

Start date

2019-01-05

Completion date

2019-11-05

Last updated

2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Pregnancy, Ectopic Pregnancy

Keywords

kisspeptin, ectopic pregnancy

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTblood test

blood test (serum samples) for biochemical examination

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 37 Years

Healthy volunteers

Yes

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame	Description
Kisspeptin levels in early pregnancy	January 2019-January 2020	Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026