60 Participants NeededMy employer runs this trial

Hysteroscopy for Ectopic Pregnancy

MA
Overseen ByMargaret A Rush, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect ectopic pregnancies (when a pregnancy grows outside the uterus) in patients with fertility issues. It compares hysteroscopy, a procedure using a camera to examine the uterus, to the more invasive standard D&C method. The researchers aim to determine if hysteroscopy can diagnose and treat these pregnancies more quickly and safely. Individuals with positive pregnancy tests and unusual hormone patterns (less than a 50% increase over 48 hours) might be suitable candidates. The study aims to reduce unnecessary medication and improve the patient experience by making diagnosis and treatment faster and less invasive. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future fertility care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hysteroscopy is safe for evaluating pregnancy of unknown location?

Research has shown that hysteroscopy, a procedure to examine the inside of the uterus, is generally safe and well-tolerated. One study found that using hysteroscopy to treat ectopic pregnancies (pregnancies outside the uterus) was safe and effective for stable patients. Another study reported a relatively low complication rate of 8.2% and a high success rate of 93.6%.

These findings suggest that hysteroscopy is a minimally invasive procedure with a strong safety record, meaning most people do not experience major side effects. However, like any medical procedure, some risk of complications exists, so participants should discuss any concerns with their doctors.12345

Why are researchers excited about this trial?

Researchers are excited about using hysteroscopy for ectopic pregnancy because it offers a more precise approach compared to standard treatments like methotrexate or surgical intervention. Hysteroscopy allows doctors to directly view the uterine cavity, potentially improving the accuracy of diagnosing abnormal pregnancy tissue. This method could lead to more effective and targeted treatment, reducing the need for more invasive procedures. Additionally, by integrating a biopsy during hysteroscopy, there's an opportunity to gather more detailed information about the tissue, which could enhance treatment planning and outcomes.

What evidence suggests that hysteroscopy is effective for diagnosing pregnancy of unknown location?

Research has shown that hysteroscopy can safely and effectively manage certain types of ectopic pregnancies. For instance, studies have found that hysteroscopy in stable patients with interstitial ectopic pregnancies leads to successful outcomes. In cases of ectopic pregnancies in a cesarean scar, removing the pregnancy with hysteroscopy has proven more successful than other methods. Patients treated with hysteroscopy for uterine issues have also had a high chance of becoming pregnant afterward. In this trial, all participants will undergo a diagnostic hysteroscopy with a possible biopsy of abnormal pregnancy tissue before dilation and curettage. These findings suggest that hysteroscopy could be a promising option for diagnosing and treating pregnancies of unknown location (PUL), potentially reducing the need for more invasive procedures and speeding up treatment times.12567

Are You a Good Fit for This Trial?

This trial is for adults with a positive pregnancy test and an early pregnancy that isn't growing as expected, shown by slow-rising hCG levels over several days. It includes those who conceived naturally or through fertility treatments. People with known uterine abnormalities or serious medical emergencies can't join.

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
See 1 more

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

Trial Overview

The study compares two ways to diagnose and treat pregnancies of unknown location: office hysteroscopy (a camera procedure in the uterus) versus standard D&C (uterine aspiration). Both procedures are done on each participant, and their results are compared.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Hysteroscopy prior to Dilation and CurettageExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

The impact of operative hysteroscopy on pregnancy outcomes ...

Specifically, the multivariate model indicated that hysteroscopic surgery increased the clinical pregnancy rate by 54.3% and the live birth rate by 44.2%.

Analysis of the Clinical Efficacy of Laparoscopy and ...

Results: Of the 278 patients, 129 got pregnant (pregnancy rate = 46.4%). Pelvic adhesions, hydrosalpinx, twisted/folded fallopian tubes, and ...

The Role of Hysteroscopy for the Treatment of Interstitial ...

Conclusions: Hysteroscopic management is a safe and effective minimally invasive option for clinically stable patients with interstitial ectopic pregnancy. It ...

The Value of Routine Hysteroscopy Before First Embryo ...

In summary, our findings indicate that routine hysteroscopy before embryo transfer did not significantly improve most reproductive outcomes in ...

Hysteroscopic resection effective for treating cesarean scar ...

In a recent study, cesarean scar ectopic pregnancy treatment was more often successful when using hysteroscopic resection vs ultrasound-guided ...

Hysteroscopic resection as a safe minimally invasive ... - PMC

Hysteroscopic resection of ectopic cornual pregnancy following MRI imaging is a safe and effective treatment option without significantly impacting fertility ...

Hysteroscopic treatment and reproductive outcomes in ...

The rates of complications and success were 8.2% and 93.6%, respectively. Thirty-seven women conceived again, and 22 women completed a term pregnancy with no ...