Comparison of Surgical Management of Early Pregnancy Loss by Suction Curettage Versus Hysteroscopy in Patients Undergoing In-vitro Fertilization (IVF)

NCT07143578 | Recruiting

• 1 other identifier: 0162-25-ASF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Early pregnancy loss occurs in \~15% of pregnancies. The treatment options include surgical uterine evacuation by suction curettage, medical management with misoprostol, or conservative management without interventions. The advantages of surgical management include quick resolution of the pregnancy and avoidance of heavy vaginal bleeding, while the disadvantages include retained products of conception and intrauterine adhesion formation which could affect future fertility. With the aim of reducing the complications of suction curettage, uterine evacuation using operative hysteroscopy has been suggested. In a previous study, the investigators compared suction curettage with operative hysteroscopy for the surgical management of early pregnancy loss up to 10 weeks of gestation. The results showed significantly reduced adhesions rate (4.2% in the hysteroscopy group vs. 45.2% in the suction group, p \< 0.01), although the operative time was significantly longer for the hysteroscopy. In this follow-up study, the investigators will compare the outcomes of hysteroscopy and suction curettage in a select group of patients with early pregnancy loss following conception by in-vitro fertilization. These patients are at risk for adhesions and therefore candidates for the hysteroscopic intervention. The study will include 50 patients randomized to 2 intervention arms - hysteroscopy using a tissue removal device versus the standard suction curettage. Post-operative adhesions will be assessed by office hysteroscopy after 6-8 weeks.

Conditions

Early Abortion; Pregnancy Loss, Early

Keywords

hysteroscopy; pregnancy loss; early missed abortion; spontaneous abortion; suction curettage; intrauterine adhesions

Outcome Measures

Primary Outcomes (2)

• Intrauterine adhesions

  Post-operative intrauterine adhesions will be evaluated by office diagnostic hysteroscopy after 6-8 weeks. The physician performing the office hysteroscopy will be blinded to the patient's intervention arm. The intrauterine adhesions will be classified according to the American Fertility Society score (from 0 to 12, higher scores means worse adhesions).

  8 weeks

• Time to pregnancy

  The patient's reproductive outcomes will be assessed by telephone interview after 6 and 12 months from the intervention.

  12 months

Study Arms (2)

Operative hysteroscopy

EXPERIMENTAL

Operative hysteroscopy using tissue removal device

Device: Operative hysteroscopy using tissue removal device

Suction curretage

ACTIVE COMPARATOR

Standard suction curettage

Device: suction curettage

Interventions

Operative hysteroscopy using tissue removal device DEVICE

Operative hysteroscopy using tissue removal device

Operative hysteroscopy

suction curettage DEVICE

suction curettage using plastic scution curette

Suction curretage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Individuals who can carry a pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of early pregnancy loss up to 10 weeks' gestation, based on last menstrual period or ultrasound.
• Pregnancy conceived through assisted reproductive techniques (in vitro fertilization, IVF).
• Ability to provide informed consent, and proficiency in reading and writing Hebrew.

You may not qualify if:

• Heavy vaginal bleeding or diagnosis of incomplete abortion.
• Signs of infection and/or suspicion of septic abortion
• Known uterine anomalies- including septate, bicornuate, unicornuate, or didelphys uterus.
• Prior medical or surgical treatment during the current pregnancy
• History of intrauterine adhesions
• History of ≥ 3 prior miscarriages.
• History of ≥ 3 prior cesarean sections.
• History of myomectomy via abdominal or hysteroscopic approach.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (2)

Shamir Medical Center

Be’er Ya‘aqov, 70200, Israel

RECRUITING

Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

ACTIVE NOT RECRUITING

Related Publications (3)

• 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, Bussieres L, Fauconnier A. Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial. JAMA. 2023 Apr 11;329(14):1197-1205. doi: 10.1001/jama.2023.3415.

  PMID: 37039805 BACKGROUND

• 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. 2024 Apr;46(4):102327. doi: 10.1016/j.jogc.2023.102327. Epub 2023 Dec 1.

  PMID: 38042480 BACKGROUND

• 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 May 1;397(10285):1658-1667. doi: 10.1016/S0140-6736(21)00682-6. Epub 2021 Apr 27.

  PMID: 33915094 BACKGROUND

MeSH Terms

Conditions

Abortion, Spontaneous; Abortion, Missed; Gynatresia

Interventions

Vacuum Curettage

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Noam Smorgick, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

• Maya Naor Dovev, MD

  Assaf-Harofeh Medical Center

  STUDY DIRECTOR

Central Study Contacts

Noam Smorgick, MD

CONTACT

+972-8-9779000; gyn-endo@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MIGS

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)