NCT07072052Recruiting
Oxford Luteal Dysfunction and Placental Insufficiency Study
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
High blood pressure (BP) affects approximately 1 in 10 pregnancies. About half of women with high blood pressure in pregnancy develop a serious complication called preeclampsia, which kills over 70,000 women and 500,000 babies every year worldwide. Despite its devastating impact, scientists know little about preeclampsia prevention or treatment. Research has shown that preeclampsia results mainly from an abnormal attachment of the placenta to the lining of the womb. In the first 8 weeks of pregnancy, placental attachment depends on the release of hormones (for example, progesterone) by a gland in the ovary called the corpus luteum. Low blood levels of progesterone in early pregnancy are associated with a reduced chance of having a live baby and higher risk of miscarriage. Giving progesterone to women at risk of miscarriage in early pregnancy reduces their chance of developing preeclampsia by nearly 40%. These results highlight the crucial role of the corpus luteum in normal pregnancy, but there is a need for high-quality studies to identify women whose corpus luteum may be defective. Giving these women medicines to treat corpus luteal defects may lead to normal attachment of the placenta, reducing the risk of pregnancy complications such as preeclampsia. The investigators propose a study that will investigate whether ultrasound features of the corpus luteum and blood and urine levels of corpus luteal hormones may predict preeclampsia.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 360 (estimated)
- First submitted
- 25 Jun 2025
- Start date
- 23 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Oxford
- NCT number
- NCT07072052
What you commit to
- Study type: Observational
- Planned participants: 360
- From 23 Oct 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Frozen embryo transfer using hormone replacement therapy for endometrial preparation.
- Participation in any concurrent trials of medicinal products in pregnancy.
Other illness
- Vaginal bleeding at first visit.
Other
- Unable to read, or to understand written or spoken English.
- Miscarriage at first visit, defined as fetal crown-rump length of 7 mm or longer with no visible heartbeat, OR gestational sac with a mean of 25 mm or greater in diameter with no visible fetal pole on ultrasonography.
- Evidence of ectopic pregnancy at first visit.
- Multiple pregnancy.
- Uterine pathology (e.g., uterine polyp, fibroid, septate uterus, uterus didelphys, bicornuate uterus, unicornuate uterus).
- Fresh in vitro fertilisation.
- Donor oocyte in vitro fertilisation.
Who the study is looking for
- Participant is willing and able to give written informed consent for participation in the study.
- Female, aged 16 years or above. As in vitro fertilisation is not undertaken in women younger than 18 years, those with pregnancies resulting from natural cycle frozen embryo transfer will be aged 18 years or above.
- Pregnancy \<8 completed weeks of gestation (i.e., up to 7 weeks and 6 days' gestation).
- Conception through any of the following means: unassisted ("natural"), ovulation induction (with clomifene citrate, letrozole or gonadotropin injections, including trigger injection), intrauterine insemination (with or without ovulation induction, including trigger injection), or natural cycle frozen embryo transfer.
- Intrauterine viable pregnancy confirmed on research ultrasound scan.
- Intention to deliver at Oxford University Hospitals.
Age in the registry: 16 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.