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Completed

NCT Number: NCT04371991

Kisspeptin Levels in Early Pregnancy

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.

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Key information

Age range

18 year–37 year

Sex eligibility

Female

Study type

Observational

Primary location

Gaziosmanpasa Taksim Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Diagnostic Test

blood test (serum samples) for biochemical examination

Primary outcomes

  1. Kisspeptin levels in early pregnancy

    Time frame: January 2019-January 2020

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

Sponsors and collaborators

Lead sponsor

Semra Yuksel

Other Gov

Registry information

Official study title

Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 1, 2020
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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