Hysteroscopy for Ectopic Pregnancy

Overseen By Margaret A Rush, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Abnormal cavity, Hemodynamic instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

Patients undergoing care with positive serum hcg and 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

Exclusion Criteria

I have a history of fibroids or an abnormal uterus shape.

I do not have unstable blood pressure or a sudden severe belly problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diagnostic Procedure

Participants undergo hysteroscopy with possible biopsy followed by uterine aspiration (D&C) to diagnose ectopic pregnancy or treat abnormal intrauterine pregnancy

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Serum bHCG levels are drawn on post-operative day 1 to determine the need for methotrexate therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Hysteroscopy

How Is the Trial Designed?

Group I: Hysteroscopy prior to Dilation and Curettage Experimental Treatment 1 Intervention

All patients in this study will have a diagnostic hysteroscopy with possible biopsy of abnormal pregnancy tissue prior to dilation and curettage

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

American Society for Reproductive Medicine

Collaborator

Trials

1

Recruited

190+