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Completed

NCT Number: NCT07204028

Early Pregnancy Ultrasound Parameters Including Corpus Luteum Doppler in Prediction of First Trimester Pregnancy Outcome in Spontaneous Pregnancies.

The synthesis of progesterone by corpus luteum is extremely important for the maintenance of normal pregnancy in the first seven weeks. Similarly, the production of progesterone by the placental syncytiotrophoblast increases progressively during the first weeks of gestation, so that in eight and a half weeks the placenta and corpus luteum contribute in equal amounts of progesterone. However, from the eighth week, the placental contribution is sufficient to maintain gestation. Angiogenesis in the corpus luteum occurs under physiologic circumstances in each menstrual cycle and functionally is very important for maintenance of early pregnancy. This role implies a potential correlation between abnormal function of corpus luteum and possible abnormal pregnancy including abortion. Using color Doppler sonography, it was feasible to distinguish the ovary containing an active corpus luteum from the inactive ovary. The technique is simple to use, and the results are displayed obviously.

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Key information

Conditions

Fetal Conditions

Age range

Up to 40 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine, Cairo University

Giza, Cairo Governorate, 4240310, Egypt

About this study

Gestational sac (GS), yolk sac (YS), crown-rump length (CRL), and heart rate (HR) and corpus luteum Doppler are the parameters measured to evaluate early pregnancy. Deviations in the ultrasound parameters have been alternatively investigated to predict first trimester pregnancy loss. The amniotic sac, which becomes visible at the beginning of the 7th week of gestation, is normally not contemplated in the prediction models, however it assists in dating a pregnancy correctly.

The aim of this study is to evaluate gestational sac diameter (GSD), yolk sac diameter (YSD), heart rate (HR), CRL and corpus luteum Doppler at 6-12 gestational weeks (GW) as predictors of first trimester outcome.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The age of women in the studied population was up to 40 years.
  • Live singleton pregnancy with gestational age 6-9 gestational weeks.
  • Patients with threatened miscarriage were included.

Exclusion criteria

  • Ectopic pregnancy.
  • Multiple pregnancies.
  • Vesicular mole.
  • Miscarriage in first visit.
  • Fetal anomaly.
  • Known uterine anomalies.
  • Significant pre-pregnancy maternal diseases (e.g., hypertension - diabetes mellitus-systemic lupus) or known thrombophilia (e.g., antiphospholipid syndrome).

Treatment and study plan

Primary outcomes

  1. New predictors of first trimester pregnancy outcome

    Time frame: 6 months

    Evaluation of corpus luteum Doppler as predictor of first trimester outcome.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Corpus Luteum Doppler in Prediction of First Trimester Pregnancy Outcome

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2025
Registry last updated
Mar 2, 2026

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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