Pre-Surgical Grading System of Asherman Syndrome

NCT05901948 | Completed

• 1 other identifier: 100032023002
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3 groups based on expected difficulty of surgery and potential prognostic outcomes.

Conditions

Asherman Syndrome

Keywords

Asherman Syndrome; Hysteroscopy; Intra-Uterine Surgery; Intra-Uterine Adhesions; Classification

Outcome Measures

Primary Outcomes (1)

• Percentage Resumption of normal cavity on hystero-salpingography

  assessing the improvement of the cavity of the uterus in hystero-salpingography

  1 month

Secondary Outcomes (1)

• Menses

  3 months

Study Arms (1)

Asherman Patients

Patients diagnosed with Asherman syndrome based on patient complaint of hypomenorrhea or amenorrhea and hysterosalpingography.

Other: Classification

Interventions

Classification OTHER

Novel Asherman Scoring Classification

Asherman Patients

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients complaining of hypomenorrhea, amenorrhea or infertility, who have a hysterosalpingography confirming intrauterine adhesions (Asherman Syndrome)

You may qualify if:

• Asherman Syndrome
• intra-uterine synechiae

You may not qualify if:

• patients with a fundectomy or uterine reduction surgery.

Sponsors & Collaborators

• Ebtesama Hospital: lead

Study Sites (1)

Ebtesama Hospital

Cairo, 11341, Egypt

Location

Related Publications (3)

• Dreisler E, Kjer JJ. Asherman's syndrome: current perspectives on diagnosis and management. Int J Womens Health. 2019 Mar 20;11:191-198. doi: 10.2147/IJWH.S165474. eCollection 2019.

  PMID: 30936754 RESULT

• Salazar CA, Isaacson K, Morris S. A comprehensive review of Asherman's syndrome: causes, symptoms and treatment options. Curr Opin Obstet Gynecol. 2017 Aug;29(4):249-256. doi: 10.1097/GCO.0000000000000378.

  PMID: 28582327 RESULT

• Di Guardo F, Della Corte L, Vilos GA, Carugno J, Torok P, Giampaolino P, Manchanda R, Vitale SG. Evaluation and treatment of infertile women with Asherman syndrome: an updated review focusing on the role of hysteroscopy. Reprod Biomed Online. 2020 Jul;41(1):55-61. doi: 10.1016/j.rbmo.2020.03.021. Epub 2020 Apr 28.

  PMID: 32444259 RESULT

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

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

Study Officials

• Osama Shawki, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endoscopy unit director

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 13, 2023
• Study Start: January 7, 2020
• Primary Completion: January 31, 2023
• Study Completion: March 15, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after completion

Locations

EG (1)