Office hysteroscopy to diagnose and treat a pregnancy of unknown location
Official title: Hysteroscopy for the Diagnosis and Treatment of Pregnancy of Unknown Location
Run by University of Pennsylvania · NCT07469605 · Data updated 2026-11-12
This will test whether office hysteroscopy can safely diagnose and sometimes treat early pregnancies not visible on ultrasound in people with a pregnancy of unknown location.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT07469605 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with a positive serum hCG, an abnormal hCG trend (less than 50% rise over 48 hours repeated across three values), well-established pregnancy dating, and no known uterine cavity abnormalities.
✕Probably not a fit
Patients with known uterine anomalies, hemodynamic instability, an acute abdomen, or those whose pregnancy is already visible on ultrasound are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with a positive serum hCG and an abnormal hCG rise pattern who have a well-dated early pregnancy but no intrauterine pregnancy on ultrasound will undergo office hysteroscopy with targeted biopsy. The hysteroscopic specimen will be compared to the gold-standard dilation and curettage (D&C) specimen and pathologic evaluation for chorionic villi. If chorionic villi are absent on pathology the diagnosis of ectopic pregnancy is often made and methotrexate is recommended, so the study tests whether hysteroscopy can provide equivalent diagnostic information without an operating-room D&C. The goal is to shorten time to diagnosis and treatment, reduce anesthesia and OR use, and offer a safe, office-based alternative for selected patients with a pregnancy of unknown location.
Why it matters
Potential benefit: If successful, patients could receive faster diagnosis and treatment without a delayed operating-room D&C or general anesthesia.
How similar studies have gone: Office hysteroscopy is known to be safe and well tolerated for evaluating the uterine cavity, but direct comparisons to D&C specifically for pregnancy of unknown location are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Penn Fertility Care
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Margaret A Rush, MD
- Email: margaret.rush@pennmedicine.upenn.edu
- Phone: 267-624-4249
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
At-home urine test for managing pregnancy of unknown location
This study is testing an at-home urine test for women with pregnancy of unknown location to see if it can accurately track hormone levels and reduce the need for extra doctor visits.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.