Uterine SeptumNCT06315582
Surgical Approach to Uterine Septum
A study testing Removal of uterine septum with hysteroscopic scissors without electrosurgery. and Hysteroscopic septoplasty utilizing bipolar electrosurgery in people with Uterine Septum and Surgical Complication, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures. Read more about this study
- Who is it for?
- Ages 22 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Septum, Surgical Complication, Septum; Uterus
- What is being tested?
- Removal of uterine septum with hysteroscopic scissors without electrosurgery. and Hysteroscopic septoplasty utilizing bipolar electrosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to Dec 2026
- 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 22 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a confirmed septum (>1.0 cm) confirmed with 3D imaging and/or MRI
- 20-44 years old
Who cannot join
- Known tubal disease
- Bleeding diastasis
- No blood thinners
- No concurrent laparoscopy scheduled
- Patient with confirmed fibroids over >1 cm FIGO (International Federation of Gynecology and Obstetrics) type 1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Milad Madgy, MD contact
United States1 site, 1 recruiting
- Recruiting
Northwestern Medicine Prentice Women's Hospital
Chicago, Illinois, 60611
Milad Madgy, MD, mmilad@nm.org
About this study
Official title: Surgical Approach to Uterine Septum: A Randomized Controlled Trial
The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.
Read the detailed description
This study is being done to compare two different surgical techniques that can be used to remove the uterine septum. At Northwestern, both procedures are done routinely. Surgeon preference and comfort dictates which is offered. Both techniques are thought to achieve the same goal of removing the participants septum with a procedure called a hysteroscopy in which the participants are taken to the operating room and a scope with a camera is inserted inside their uterus while it is expanded with sterile water. The difference is the instrument used to remove the septum. One technique uses scissors without electricity or heat followed by removal of the excess tissue with a thin tube using suction. The other technique uses an electrical loop (electrosurgery) to cut and remove the tissue. The investigators will be comparing these two procedures by measuring things such as operative time, cost, and the amount of fluid (saline) the participants body absorbs. As mentioned above, to visualize the inside of the participants uterus, the investigators will expand it by filling it with saline.Some of this fluid is absorbed by the walls of the uterus and is routinely measured. This will be one of the measurements used to compare the two surgical techniques.
About 4 weeks after the participants procedure they will have a routine follow up visit to determine if there is any septum left. The investigators will do this by doing an in-office hysteroscopy at this appointment. This might be a simple vaginal ultrasound, ultrasound with saline or a follow up hysteroscopy. If there remains some septum, it would be removed during a second hysteroscopy. It is common to need a second or even third procedure to completely remove the septum. The investigators anticipate the two techniques being compared will have similar success rates in removing the uterine septum, although there is some data to suggest that the current standard of care procedure which is using electrosurgery could cause additional adhesive disease and require another procedure to remove the adhesions. Currently, there is little data comparing these two techniques and so this study will help us understand if one causes more adhesions or not.
- Being tested
- Removal of uterine septum with hysteroscopic scissors without electrosurgery., Hysteroscopic septoplasty utilizing bipolar electrosurgery
- Medical subject headings
- Septate Uterus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of uterine septum with hysteroscopic scissors without electrosurgery.Procedure or surgery
Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue
Hysteroscopic septoplasty utilizing bipolar electrosurgeryProcedure or surgery
Hysteroscopic septoplasty utilizing bipolar electrosurgery
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention A (control group) | Active comparator | Hysteroscopic septoplasty utilizing bipolar electrosurgery Receives: Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgery |
| Study Intervention B (study group) | Experimental | Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue Receives: Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-level variables: operative time hysteroscopic septoplasty
We will measure time it takes to conduct procedure
Measured: During the intervention/procedure/surgery
Procedure-level variables: Surgical Cost
We will compare amount of money spent.
Measured: During the surgery
Procedure-level variables: Fluid deficit
We will measure amount of fluid deficit which is a number that is generate by hysteroscope.
Measured: During the surgery
Resolution of uterine septum
Compare septum resolution defined by being less than 1 cm in depth from the intertubal line and need for additional intervention following hysteroscopic septoplasty utilizing these two surgical techniques
Measured: Assess at 4 weeks post-op hysteroscopy
Secondary outcomes (2)
Compare adverse events
Characterize and compare any potential adverse events related to the two surgical techniques for hysteroscopic septoplasty
Measured: Immediate period-- 1 week post-operation
Comparing patient recovery and satisfaction
Comparing patient recovery and satisfaction with follow up post-operative phone calls with standardized questions
Measured: 2 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start11 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Uterine SeptumStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized single blinded study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Milad, MD, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315582
- Sponsor's protocol ID
- STU00220487
- Status last verified
- May 2026
- First submitted
- 27 Feb 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalaitzopoulos DR, Themeli MZ, Grigoriadis G, Alterio MD, Vitale SG, Angioni S, Daniilidis A. Fertility, pregnancy and perioperative outcomes after operative hysteroscopy for uterine septum: a network meta-analysis. Arch Gynecol Obstet. 2024 Mar;309(3):731-744. doi: 10.1007/s00404-023-07109-2. Epub 2023 Jun 24.
PubMed 37354236Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.
PubMed 27235766Dason ES, Mathur S, Murji A. Hysteroscopic septoplasty: many techniques, little evidence. Fertil Steril. 2021 Nov;116(5):1426-1427. doi: 10.1016/j.fertnstert.2021.09.001. Epub 2021 Oct 1. No abstract available.
PubMed 34607705Budden A, Abbott JA. The Diagnosis and Surgical Approach of Uterine Septa. J Minim Invasive Gynecol. 2018 Feb;25(2):209-217. doi: 10.1016/j.jmig.2017.07.017. Epub 2017 Jul 26.
PubMed 28755995Yang L, Wang L, Chen Y, Guo X, Miao C, Zhao Y, Li L, Zhang Q. Cold scissors versus electrosurgery for hysteroscopic adhesiolysis: A meta-analysis. Medicine (Baltimore). 2021 Apr 30;100(17):e25676. doi: 10.1097/MD.0000000000025676.
PubMed 33907137Fatehi Hassanabad A, Zarzycki AN, Jeon K, Dundas JA, Vasanthan V, Deniset JF, Fedak PWM. Prevention of Post-Operative Adhesions: A Comprehensive Review of Present and Emerging Strategies. Biomolecules. 2021 Jul 14;11(7):1027. doi: 10.3390/biom11071027.
PubMed 34356652Carrera M, Perez Millan F, Alcazar JL, Alonso L, Caballero M, Carugno J, Dominguez JA, Moratalla E. Effect of Hysteroscopic Metroplasty on Reproductive Outcomes in Women with Septate Uterus: Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2022 Apr;29(4):465-475. doi: 10.1016/j.jmig.2021.10.001. Epub 2021 Oct 11.
PubMed 34648934LaMonica R, Pinto J, Luciano D, Lyapis A, Luciano A. Incidence of Septate Uterus in Reproductive-Aged Women With and Without Endometriosis. J Minim Invasive Gynecol. 2016 May-Jun;23(4):610-3. doi: 10.1016/j.jmig.2016.02.010. Epub 2016 Feb 23.
PubMed 26922877
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Approach to Uterine Septum: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06315582
- Acronym / sponsor ID
- STU00220487
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Mar 2024 (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.
The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.
Detailed description
This study is being done to compare two different surgical techniques that can be used to remove the uterine septum. At Northwestern, both procedures are done routinely. Surgeon preference and comfort dictates which is offered. Both techniques are thought to achieve the same goal of removing the participants septum with a procedure called a hysteroscopy in which the participants are taken to the operating room and a scope with a camera is inserted inside their uterus while it is expanded with sterile water. The difference is the instrument used to remove the septum. One technique uses scissors without electricity or heat followed by removal of the excess tissue with a thin tube using suction. The other technique uses an electrical loop (electrosurgery) to cut and remove the tissue. The investigators will be comparing these two procedures by measuring things such as operative time, cost, and the amount of fluid (saline) the participants body absorbs. As mentioned above, to visualize the inside of the participants uterus, the investigators will expand it by filling it with saline.Some of this fluid is absorbed by the walls of the uterus and is routinely measured. This will be one of the measurements used to compare the two surgical techniques.
About 4 weeks after the participants procedure they will have a routine follow up visit to determine if there is any septum left. The investigators will do this by doing an in-office hysteroscopy at this appointment. This might be a simple vaginal ultrasound, ultrasound with saline or a follow up hysteroscopy. If there remains some septum, it would be removed during a second hysteroscopy. It is common to need a second or even third procedure to completely remove the septum. The investigators anticipate the two techniques being compared will have similar success rates in removing the uterine septum, although there is some data to suggest that the current standard of care procedure which is using electrosurgery could cause additional adhesive disease and require another procedure to remove the adhesions. Currently, there is little data comparing these two techniques and so this study will help us understand if one causes more adhesions or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized single blinded study
| Arm | Type | Receives |
|---|---|---|
| Study Intervention A (control group) | Active comparator | Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgeryHysteroscopic septoplasty utilizing bipolar electrosurgery |
| Study Intervention B (study group) | Experimental | Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery.Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue |
Who may qualify
- Ages
- 22 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a confirmed septum (>1.0 cm) confirmed with 3D imaging and/or MRI
- 20-44 years old
Key exclusion criteria (5 listed)
- Known tubal disease
- Bleeding diastasis
- No blood thinners
- No concurrent laparoscopy scheduled
- Patient with confirmed fibroids over >1 cm FIGO (International Federation of Gynecology and Obstetrics) type 1
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 |
|---|---|---|
| Removal of uterine septum with hysteroscopic scissors without electrosurgery.Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue | Procedure or surgery | Study Intervention B (study group) |
| Hysteroscopic septoplasty utilizing bipolar electrosurgeryHysteroscopic septoplasty utilizing bipolar electrosurgery | Procedure or surgery | Study Intervention A (control group) |
Primary outcome
Procedure-level variables: operative time hysteroscopic septoplasty
Time frame: During the intervention/procedure/surgery
We will measure time it takes to conduct procedure
Procedure-level variables: Surgical Cost
Time frame: During the surgery
We will compare amount of money spent.
Procedure-level variables: Fluid deficit
Time frame: During the surgery
We will measure amount of fluid deficit which is a number that is generate by hysteroscope.
Resolution of uterine septum
Time frame: Assess at 4 weeks post-op hysteroscopy
Compare septum resolution defined by being less than 1 cm in depth from the intertubal line and need for additional intervention following hysteroscopic septoplasty utilizing these two surgical techniques
2 secondary outcomes
Compare adverse events
Time frame: Immediate period-- 1 week post-operation
Comparing patient recovery and satisfaction
Time frame: 2 days postop
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 1 Jun 2026.
- Background: PubMed 37354236Kalaitzopoulos DR, Themeli MZ, Grigoriadis G, Alterio MD, Vitale SG, Angioni S, Daniilidis A. Fertility, pregnancy and perioperative outcomes after operative hysteroscopy for uterine septum: a network meta-analysis. Arch Gynecol Obstet. 2024 Mar;309(3):731-744. doi: 10.1007/s00404-023-07109-2. Epub 2023 Jun 24.
- Background: PubMed 27235766Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.
- Background: PubMed 34607705Dason ES, Mathur S, Murji A. Hysteroscopic septoplasty: many techniques, little evidence. Fertil Steril. 2021 Nov;116(5):1426-1427. doi: 10.1016/j.fertnstert.2021.09.001. Epub 2021 Oct 1. No abstract available.
- Background: PubMed 28755995Budden A, Abbott JA. The Diagnosis and Surgical Approach of Uterine Septa. J Minim Invasive Gynecol. 2018 Feb;25(2):209-217. doi: 10.1016/j.jmig.2017.07.017. Epub 2017 Jul 26.
- Background: PubMed 33907137Yang L, Wang L, Chen Y, Guo X, Miao C, Zhao Y, Li L, Zhang Q. Cold scissors versus electrosurgery for hysteroscopic adhesiolysis: A meta-analysis. Medicine (Baltimore). 2021 Apr 30;100(17):e25676. doi: 10.1097/MD.0000000000025676.
- Results publication: PubMed 34356652Fatehi Hassanabad A, Zarzycki AN, Jeon K, Dundas JA, Vasanthan V, Deniset JF, Fedak PWM. Prevention of Post-Operative Adhesions: A Comprehensive Review of Present and Emerging Strategies. Biomolecules. 2021 Jul 14;11(7):1027. doi: 10.3390/biom11071027.
- Results publication: PubMed 34648934Carrera M, Perez Millan F, Alcazar JL, Alonso L, Caballero M, Carugno J, Dominguez JA, Moratalla E. Effect of Hysteroscopic Metroplasty on Reproductive Outcomes in Women with Septate Uterus: Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2022 Apr;29(4):465-475. doi: 10.1016/j.jmig.2021.10.001. Epub 2021 Oct 11.
- Results publication: PubMed 26922877LaMonica R, Pinto J, Luciano D, Lyapis A, Luciano A. Incidence of Septate Uterus in Reproductive-Aged Women With and Without Endometriosis. J Minim Invasive Gynecol. 2016 May-Jun;23(4):610-3. doi: 10.1016/j.jmig.2016.02.010. Epub 2016 Feb 23.
- 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.
Milad Madgy, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of uterine septum with hysteroscopic scissors without electrosurgery. and Hysteroscopic septoplasty utilizing bipolar electrosurgery in people with Uterine Septum and Surgical Complication, run by Northwestern University 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 2 inclusion and 5 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 1 Jun 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 Sarah L Rodriguez, MD (7863011284, sarah.rodriguez@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-level variables: operative time hysteroscopic septoplasty (time frame: During the intervention/procedure/surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315582, which also lists 8 linked publications.
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 1 Jun 2026.