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NCT07469605 · ClinicalTrials.gov registry record · NA
Hysteroscopy for the Diagnosis and Treatment of Pregnancy of Unknown Location
A NA study of Pregnancy of Unknown Location, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07469605 is a NA study of Pregnancy of Unknown Location that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07469605, a NA study of Pregnancy of Unknown Location, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Infertility patients have a higher baseline risk of ectopic pregnancy compared to the general population. If an early pregnancy is not visible by ultrasound, patients with a pregnancy of unknown location (PUL) will undergo uterine aspiration (D\&C) in order to diagnose an ectopic pregnancy and/or treat an abnormal intrauterine pregnancy destined for miscarriage. If the pathologic specimen obtained after D\&C does not contain chorionic villi, the presumptive diagnosis of ectopic pregnancy is made and methotrexate therapy is typically recommended. In many institutions, a D\&C must be scheduled in the operating room so that it may be performed under anesthesia, potentially delaying the urgent treatment of ectopic pregnancy. Office hysteroscopy is a safe and well-tolerated means of evaluating the uterine cavity, though little literature exists supporting its use in the evaluation of PUL. The objective of this study is to compare hysteroscopic biopsy to the gold standard D\&C for the diagnosis and treatment of PUL. The investigators propose a prospective study including patients undergoing care at the University of Pennsylvania. Patients will be included if they have at least three bHCG values demonstrating a \<50% increase in over 48 hours. A hysteroscopy with possible biopsy followed by uterine aspiration will be performed, and the final pathology results will be compared. Although pathology results from the procedure are considered the gold standard of diagnosis, physicians typically do not wait for results to return before proceeding with necessary treatment. Instead, all patients will have a serum bHCG drawn on post-operative day 1, and those with a \<50% decrease compared to pre-procedural values will undergo treatment with methotrexate therapy per institutional protocol. The findings from this pilot study will inform future research comparing hysteroscopic vs. D\&C for management of PUL. If hysteroscopic targeted biopsy is more accurate than D\&C in detecting an
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Hysteroscopy for diagnosis and treatment of pregnancy of unknown location
Study Locations (1)
Pennsylvania
- Penn Fertility Care - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-01-15 |
| Est. Completion | 2027-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07469605
The ClinicalTrials.gov registry entry for NCT07469605 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pregnancy of Unknown Location appearing as the primary indexed condition, and to 1 intervention - of which Hysteroscopy for diagnosis and treatment of pregnancy of unknown location is the first listed.
NCT07469605 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07469605 about?
NCT07469605 is a clinical study titled "Hysteroscopy for the Diagnosis and Treatment of Pregnancy of Unknown Location". Infertility patients have a higher baseline risk of ectopic pregnancy compared to the general population. If an early pregnancy is not visible by ultrasound, patients with a pregnancy of unknown location (PUL) will undergo uterine aspiration (D\&C) in order to diagnose an ectopic pregnancy and/or tr...
What is the current status of trial NCT07469605?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2026-01-15. Estimated completion is 2027-01-01.
What conditions does trial NCT07469605 study?
This clinical trial studies the following conditions: Pregnancy of Unknown Location.
What interventions are being tested in trial NCT07469605?
The interventions under investigation include: Hysteroscopy for diagnosis and treatment of pregnancy of unknown location (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07469605?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07469605 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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