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Kisspeptin Levels in Early Pregnancy

S

Semra Yuksel

Status

Completed

Conditions

Ectopic Pregnancy
Early Pregnancy

Treatments

Diagnostic Test: blood test

Study type

Observational

Funder types

Other

Identifiers

NCT04371991
GaziosmanpasaTREH20

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

Female

Ages

18 to 37 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

88 participants in 4 patient groups

Group 1
Description:
Ectopic pregnancy
Treatment:
Diagnostic Test: blood test
Group 2
Description:
Early viable pregnancy
Treatment:
Diagnostic Test: blood test
Group 3
Description:
incomplete miscarriage
Treatment:
Diagnostic Test: blood test
Group 4
Description:
Healthy women
Treatment:
Diagnostic Test: blood test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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