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Early Pregnancy LossNCT06309927

Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage)

A study testing Operative hysteroscopy (by tissue removal device) and Suction curettage in people with Early Pregnancy Loss and Intrauterine Adhesion, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Early Pregnancy Loss, Intrauterine Adhesion
What is being tested?
Operative hysteroscopy (by tissue removal device) and Suction curettage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIsrael
Study dates
1 Apr 2024to Feb 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 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Early pregnancy loss (miscarriage) up to 10 gestational weeks
  • Able to give informed consent, and read/write in Hebrew

Who cannot join

  • Incomplete abortion presenting as heavy vaginal bleeding and dilated cervix
  • Signs of infection and/or suspicion of septic abortion
  • Previous diagnosis of Mullerian anomalies - septate, bicornuate, unicornuate or didelphi uterus
  • Previous medical or surgical treatment in the current pregnancy
  • Previous diagnosis or past surgery for intrauterine adhesions
  • History of 2 or more prvious miscarriages
  • History of 2 or more cesarean sections
  • History of abdominal, vaginal or hysteroscopic myomectomy

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Shamir Medical Center

    Be’er Ya‘aqov, 70200

Other trials in Israel

About this study

Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.

Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study:

Read more
  1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)
  2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group).

The surgical procedure will be determined randomly by computer generated allocation.

All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team.

Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge.

One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications.

A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed.

6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies.

Read the detailed description

Early pregnancy loss occurs in ~ 15% of all pregnancies, while 10% of women have experienced at least one pregnancy loss. The therapeutic options that are available in these cases include surgical termination of pregnancy by suction curettage, medical treatment with Misoprostol, and conservative management. The surgical termination of pregnancy allows for relatively quick termination of the pregnancy, and prevention of heavy vaginal bleeding requiring urgent curettage. However, although this is a common and relatively safe procedure, it is associated with risks such as infection, residual trophoblastic tissue or retained products of conception (RPOC), bleeding and uterine perforation. In the long term, there is a risk of intrauterine adhesions formation, which may cause infertility and in severe cases, Asherman's syndrome. It has been hypothesized that RPOC following suction curettage occur because it is a "blind" operation. Therefore, it is now common practice to use ultrasound imaging during and/or immediately after the procedure in order to verify that all the pregnancy contents have been removed. However, despite the use of ultrasound, RPOCs are diagnosed in 1% to 10% of these procedures. Intrauterine adhesions following suction curettage are another significant risk of these procedures. In a study by Hooker et al., intrauterine adhesions were found in approximately 20% of suction curettage cases, while in women with repeated miscarriages the risk of intrauterine adhesions was even higher. Intrauterine adhesions are of critical importance in women of childbearing age, as they may cause infertility, menstrual disorders, and recurrent miscarriages. Therefore, preventing adhesions or reducing the rate of adhesions after surgical emptying of the uterine cavity is an issue of utmost importance in women of childbearing age. Thus, in recent years, several studies have investigated the use of operative hysteroscopy for surgical evacuation of early pregnancy loss. Hysteroscopy allows a visual assessment of the uterine cavity (as opposed to a "blind" suction curettage), possibly reducing the rates of RPOC. RPOC. In addition, during hysteroscopy, the surgery is limited to the pregnancy implantation site, as opposed to the "global" suction curettage. This may allow for reducing the risk of postoperative intrauterine adhesions. These advantages of hysteroscopy compared to the blind suction curettage have been previously shown regarding a similar procedure, removal of RPOC by hysteroscopy compared to curettage, and nowadays it is indeed acceptable to remove RPOC primarily by hysteroscopy. Thus, it can be hypothesized that operative hysteroscopy for the management of early pregnancy loss compared with suction curettage may be associated with reduced rates of RPOC and postoperative intrauterine adhesions. On the other hand, operative hysteroscopy does have some disadvantages compared with suction curettage - it requires expensive equipment, a slightly longer operative time, and skilled surgeons. To date, few studies (mainly case series or small cohort studies) have been carried out regarding the use of hysteroscopy for surgical evacuation of early pregnancy loss. These studies found that it is an effective (feasible) and safe operation. Weinberg et al. used the hysteroscopic tissue removal device for surgical evacuation of early pregnancy loss up to 10th weeks in 10 patients. The procedure could be completed in 8 patients, and there were no significant complications. Bar-on et al. bipolar loop resectoscope in 15 women with early pregnancy loss up to 12 weeks, without short term complications. More recently, a multicenter comparative prospective study from France was published by Huchon et al. In this study, no differences were found in the rate of subsequent pregnancies. However, this study included patients who were not candidates for hysteroscopy (such as patients admitted incomplete abortion). To conclude, further comparative studies are needed to determine the benefits of operative hysteroscopy in patients with early pregnancy loss. In the present study, the investigators will perform a prospective comparison between surgical evacuation of early pregnancy loss by surgical hysteroscopy using the tissue removal device method versus the traditional suction curettage. The investigators will evaluate both the feasibility and safety (both short and long term) of the procedures, including an assessment of postoperative intrauterine adhesions.

Being tested
Operative hysteroscopy (by tissue removal device), Suction curettage
Keywords
hysteroscopy, curettage, early pregnancy loss, tissue removal device
Medical subject headings
Abortion, Spontaneous, Gynatresia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Operative hysteroscopy (by tissue removal device)Procedure or surgery

    Surgical evacuation of the uterine cavity using the Truclear Mini-Elite hysteroscopic tissue removal device

  • Suction curettageProcedure or surgery

    Surgical evacuation of the uterine cavity with electrical vacuum suction curette

Study groups in NCT06309927
Study groupRoleWhat they receive
Operative hysteroscopyExperimentalSurgical evacuation of the uterine cavity by operative hysteroscopy (tissue removal device, Truclear Mini-Elite)
Receives: Procedure: Operative hysteroscopy (by tissue removal device)
Suction curettageActive comparatorSurgical evacuation of the uterine cavity by ultrasound guided suction curettage
Receives: Procedure: Suction curettage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operative complications

    Short term surgical complications including estimated blood loss > 500 ml, fluid deficit > 2500 ml, uterine perforation, re-admission, fever

    Measured: 1 week

  2. Intrauterine adhesions

    Assessment of intrauterine adhesions by diagnostic office hysteroscopy

    Measured: 6 weeks

  3. Subsequent fertility

    Rates of subsequent pregnancy

    Measured: 6 months

Secondary outcomes (1)
  1. Conversion from operative hysteroscopy to suction curettage

    Inability to complete uterine evacuation by operative hysteroscopy

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion30 Mar 2025
  4. Study completionFeb 2026 (estimated)

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06309927
Sponsor's protocol ID
0025-24-ASF
Status last verified
Jan 2026
First submitted
7 Mar 2024
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 1. Quenby S, Gallos ID, Dhillon-Smith RK, Podesek M, Stephenson MD, Fisher J, Brosens JJ, Brewin J, Ramhorst R, Lucas ES, McCoy RC, Anderson R, Daher S, Regan L, Al-Memar M, Bourne T, MacIntyre DA, Rai R, Christiansen OB, Sugiura-Ogasawara M, Odendaal J, Devall AJ, Bennett PR, Petrou S, Coomarasamy A. Miscarriage matters: the epidemiological, physical, psychological, and economic costs of early pregnancy loss. Lancet. 2021;397:1658-1667. 2. ACOG Practice Bulletin No. 200 Summary: Early Pregnancy Loss. Obstet Gynecol. 2018;132:1311-1313. 3. Shaker M, Smith A. First Trimester Miscarriage. Obstet Gynecol Clin North Am. 2022;49:623-635. 4. Upadhyay UD, Desai S, Zlidar V, Weitz TA, Grossman D, Anderson P, Taylor D. Incidence of emergency department visits and complications after abortion. Obstet Gynecol. 2015;125:175-183. 5. Paul ME, Mitchell CM, Rogers AJ, Fox MC, Lackie EG. Early surgical abortion: efficacy and safety. Am J Obstet Gynecol. 2002;187:407-11. 6. Hooker A, Fraenk D, Brölmann H, Huirne J. Prevalence of intrauterine adhesions after termination of pregnancy: a systematic review. Eur J Contracept Reprod Health Care. 2016;21:329-35. 7. Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008;89:759-79. 8. Catena U, D'Ippolito S, Campolo F, Dinoi G, Lanzone A, Scambia G. Hysteroembryoscopy and hysteroscopic uterine evacuation of early pregnancy loss: A feasible procedure in selected cases. Facts Views Vis Obgyn. 2022;14:193-197. 9. Young S, Miller CE. Hysteroscopic resection for management of early pregnancy loss: a case report and literature review. F S Rep. 2022;3:163-167. 10. Smorgick N, Barel O, Fuchs N, Ben-Ami I, Pansky M, Vaknin Z. Hysteroscopic management of retained products of conception: meta-analysis and literature review. Eur J Obstet Gynecol Reprod Biol. 2014;173:19-22. 11. Barel O, Krakov A, Pansky M, Vaknin Z, Halperin R, Smorgick N. Intrauterine adhesions after hysteroscopic treatment for retained products of conception: what are the risk factors? Fertil Steril. 2015;103:775-9. 12. Weinberg S, Pansky M, Burshtein I, Beller U, Goldstein H, Barel O. A Pilot Study of Guided Conservative Hysteroscopic Evacuation of Early Miscarriage. J Minim Invasive Gynecol. 2021;28:1860-1867. 13. Bar-On S, Berkovitz Shperling R, Cohen A, Akdam A, Michaan N, Levin I, Rattan G, Tzur Y. Primary Resectoscopic Treatment of First-Trimester Miscarriage. J Obstet Gynaecol Can. 2023:102327. 14. Huchon C, Drioueche H, Koskas M, Agostini A, Bauville E, Bourdel N, Fernandez H, Fritel X, Graesslin O, Legendre G, Lucot JP, Panel P, Raiffort C, Giraudet G, Bussières L, Fauconnier A. Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial. JAMA. 2023;329:1197-1205.

Questions about this trial

What is this clinical trial studying?

A study testing Operative hysteroscopy (by tissue removal device) and Suction curettage in people with Early Pregnancy Loss and Intrauterine Adhesion, run by Assaf-Harofeh Medical Center at 1 site in Israel.

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 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 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 Israel. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operative complications (time frame: 1 week). The study lists 3 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 NCT06309927, which also lists 1 linked publication.

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 27 Jan 2026.

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