NCT07469605 Hysteroscopy for the Diagnosis and Treatment of Pregnancy of Unknown Location
| NCT ID | NCT07469605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Pregnancy of Unknown Location |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-01-15 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 abnormal IUP, this technique could reduce unnecessary methotrexate exposure in patients with abnormal IUPs. If adapted to the office setting, hysteroscopic biopsy could also shorten time to diagnosis and definitive treatment. In addition, targeted treatment in the office setting could lower the rate of intrauterine adhesions, and may improve overall the patient experience.
Eligibility Criteria
Inclusion Criteria: * Patients 18 years of age and older * Patients undergoing care with (1) positive serum hcg and (2) abnormal hcg trend, as defined by \<50% rise in bHCG over 48h period, repeated across three lab values. * Patients with pregnancy via unassisted conception, conception after ovulation induction and/or intrauterine insemination, and/or embryo transfer * Well established pregnancy dating, either with known LMP, or dating by IUI or embryo transfer Exclusion Criteria: * Patients with known abnormal cavity (history of fibroids, septum, or uterine anomaly) * Patients who are hemodynamically unstable or with an acute abdomen
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07469605 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy of Unknown Location. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07469605 currently recruiting?
Yes, NCT07469605 is actively recruiting participants. Contact the research team at margaret.rush@pennmedicine.upenn.edu for enrollment information.
Where is the NCT07469605 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07469605 clinical trial?
NCT07469605 is sponsored by University of Pennsylvania. The trial plans to enroll 60 participants.