Fetal ConditionsNCT07204028
Early Pregnancy Ultrasound Parameters Including Corpus Luteum Doppler in Prediction of First Trimester Pregnancy Outcome in Spontaneous Pregnancies.
An observational study of Fetal Conditions, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Conditions
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 21 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant female aged less than 40 years at 6-12 weeks.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Cairo University
Giza, Cairo Governorate, 4240310
About this study
Official title: Corpus Luteum Doppler in Prediction of First Trimester Pregnancy Outcome
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.
Read the detailed description
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.
- Conditions
- Fetal Conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
New predictors of first trimester pregnancy outcome
Evaluation of corpus luteum Doppler as predictor of first trimester outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal ConditionsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204028
- Sponsor's protocol ID
- Corpus luteum Doppler
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corpus Luteum Doppler in Prediction of First Trimester Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT07204028
- Acronym / sponsor ID
- Corpus luteum Doppler
- Conditions
- Fetal Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant female aged less than 40 years at 6-12 weeks.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Ectopic pregnancy.
- Multiple pregnancies.
- Vesicular mole.
- Miscarriage in first visit.
- Fetal anomaly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
New predictors of first trimester pregnancy outcome
Time frame: 6 months
Evaluation of corpus luteum Doppler as predictor of first trimester outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Conditions, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New predictors of first trimester pregnancy outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.