Pregnancy of Unknown LocationNCT07469605
Hysteroscopy for the Diagnosis and Treatment of Pregnancy of Unknown Location
A study testing Hysteroscopy for diagnosis and treatment of pregnancy of unknown location in people with Pregnancy of Unknown Location, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy of Unknown Location
- What is being tested?
- Hysteroscopy for diagnosis and treatment of pregnancy of unknown location
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with known abnormal cavity (history of fibroids, septum, or uterine anomaly)
- Patients who are hemodynamically unstable or with an acute abdomen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Fertility Care
Philadelphia, Pennsylvania, 19103
Margaret Rush Physician, MD, 215-662-2971, margaret.rush15@gmail.com
About this study
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.
- Conditions
- Pregnancy of Unknown Location
- Being tested
- Hysteroscopy for diagnosis and treatment of pregnancy of unknown location
- Keywords
- Miscarriage, Ectopic Pregnancy, Pregnancy of Unknown Location
- Medical subject headings
- Abortion, Spontaneous, Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopy for diagnosis and treatment of pregnancy of unknown locationDiagnostic test
All patients in this trial will have a diagnostic hysteroscopy performed prior to a dilation and curettage in the treatment of their pregnancy of unknown location
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopy prior to Dilation and Curettage | Experimental | All patients in this study will have a diagnostic hysteroscopy with possible biopsy of abnormal pregnancy tissue prior to dilation and curettage Receives: Diagnostic Test: Hysteroscopy for diagnosis and treatment of pregnancy of unknown location |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of abnormal tissue within the endometrial cavity
Intra-operative photographs will be taken of the participants uterine cavities at five standardized locations (left cornua, right cornua, anterior uterine wall, posterior uterine wall, and entire uterine cavity at level of internal os). The presence or absence of abnormal tissue will be documented, and findings qualitatively compared between the cavities of participants with the final diagnosis of non-viable intrauterine pregnancy and an ectopic pregnancy.
Measured: From enrollment to 1 week post-operatively
Secondary outcomes (4)
Sensitivity of hysteroscopy compared to gold-standard dilation and curettage
Sensitivity, specificity, and positive and negative predictive values of hysteroscopic biopsy as a diagnostic test will be compared to that of D\&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Measured: From enrollment to 1 week post-operatively
Specificity of hysteroscopy compared to gold-standard dilation and curettage
Specificity of hysteroscopic biopsy as a diagnostic test will be compared to that of D\&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Measured: From enrollment to 1 week post-operatively
Positive predictive value of hysteroscopy compared to gold-standard dilation and curettage
Positive predictive value of hysteroscopic biopsy as a diagnostic test will be compared to that of D\&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Measured: From enrollment to 1 week post-operatively
Negative predictive value of hysteroscopy compared to gold-standard dilation and curettage
Negative predictive value of hysteroscopic biopsy as a diagnostic test will be compared to that of D\&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Measured: From enrollment to 1 week post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy of Unknown LocationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Reproductive Medicine
- Responsible party
- Principal investigator, Clarisa Gracia, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469605
- Sponsor's protocol ID
- 859064
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopy for the Diagnosis and Treatment of Pregnancy of Unknown Location
- ClinicalTrials.gov ID
- NCT07469605
- Acronym / sponsor ID
- 859064
- Conditions
- Pregnancy of Unknown Location
- Keywords
- Miscarriage, Ectopic Pregnancy, Pregnancy of Unknown Location
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- American Society for Reproductive Medicine
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopy prior to Dilation and Curettage | Experimental | Diagnostic Test: Hysteroscopy for diagnosis and treatment of pregnancy of unknown locationAll patients in this study will have a diagnostic hysteroscopy with possible biopsy of abnormal pregnancy tissue prior to dilation and curettage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with known abnormal cavity (history of fibroids, septum, or uterine anomaly)
- Patients who are hemodynamically unstable or with an acute abdomen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopy for diagnosis and treatment of pregnancy of unknown locationAll patients in this trial will have a diagnostic hysteroscopy performed prior to a dilation and curettage in the treatment of their pregnancy of unknown location | Diagnostic test | Hysteroscopy prior to Dilation and Curettage |
Primary outcome
Presence or absence of abnormal tissue within the endometrial cavity
Time frame: From enrollment to 1 week post-operatively
Intra-operative photographs will be taken of the participants uterine cavities at five standardized locations (left cornua, right cornua, anterior uterine wall, posterior uterine wall, and entire uterine cavity at level of internal os). The presence or absence of abnormal tissue will be documented, and findings qualitatively compared between the cavities of participants with the final diagnosis of non-viable intrauterine pregnancy and an ectopic pregnancy.
4 secondary outcomes
Sensitivity of hysteroscopy compared to gold-standard dilation and curettage
Time frame: From enrollment to 1 week post-operatively
Specificity of hysteroscopy compared to gold-standard dilation and curettage
Time frame: From enrollment to 1 week post-operatively
Positive predictive value of hysteroscopy compared to gold-standard dilation and curettage
Time frame: From enrollment to 1 week post-operatively
Negative predictive value of hysteroscopy compared to gold-standard dilation and curettage
Time frame: From enrollment to 1 week post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy for diagnosis and treatment of pregnancy of unknown location in people with Pregnancy of Unknown Location, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret A Rush, MD (267-624-4249, margaret.rush@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of abnormal tissue within the endometrial cavity (time frame: From enrollment to 1 week post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.