A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri.

NCT03384082 | Unknown

• 1 other identifier: FuXingH02
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

At least 82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by three-dimensional intra-vaginal sonography (3D-TVS) and hysteroscopy, will be recruited. The subjects will be randomly divided into two groups, the experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The pregnancy rates (\>12 weeks) of the two groups will befollowed and compared.

Conditions

Arcuate Uterus

Outcome Measures

Primary Outcomes (3)

• The pregnancy rate(>12 weeks)of the two groups

  The pregnancy rate(\>12 weeks) of the two groups after receiving hysteroscopic treatment and no treatment.

  2 years

• The spontaneous abortion rate of the two groups

  The spontaneous abortion rate of the two groups after receiving hysteroscopic treatment and no treatment.

  2 years

• The live birth rate of the two groups

  Te live birth rate of the two groups after receiving hysteroscopic treatment and no treatment.

  2 years

Study Arms (2)

Hysteroscopic treatment

EXPERIMENTAL

Hysteroscopic surgery

Procedure: hysteroscopic treatment

Control group

NO INTERVENTION

No treatment

Interventions

hysteroscopic treatment PROCEDURE

treatment

Hysteroscopic treatment

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with arcuate/mild septum uteri
• Women with unexplained recurrent miscarriage (less than 12 weeks)
• Having a second time fertility requirement
• Having Informed consent before entering this study, and be willing to receive hysteroscopic treatment

You may not qualify if:

• D-TVS and hysteroscopy suggest uterine fibroids (submucosal and III type uterine fibroids, intramural fibroids,the diameter of whichis greater than 4cm), adenomyosis, endometrial polyps, intrauterine adhesions and other uterine factors that may lead to spontaneous abortion
• Endometrial pathological diagnosis of chronic endometritis, endometrial hyperplasia and endometrial cancer
• Ultrasound or HSG suggest hydrosalpinx
• Chromosome abnormalities of the couples, positive findings of pre-thrombosis state and the detection of immunity, uterine malformation, uterine fibroids, adenomyosis and other uterine factors causing recurrent miscarriage
• Semen abnormality in male
• FSH \> 10

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

Hysteroscopic Centre of Fuxing Hospital

Beijing, China

RECRUITING

Study Officials

• Dongmei Song, Ph.D

  Fuxing Hospital, Capital Medical University

  STUDY CHAIR

• Tinchiu Li, Ph.D

  Prince of Wales Hospital, Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Dongmei Song, Ph.D

CONTACT

88062220; echosdm@163.com

Yu Xiao, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 27, 2017
• Study Start: February 22, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)