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

A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri in Women With Recurrent Miscarriage.

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.

Study Overview

• Status: Unknown
• Conditions: Arcuate Uterus
• Intervention / Treatment: Procedure: hysteroscopic treatment

Detailed Description

This study will be carried out at the Hysteroscopy center of the Fuxing Hospital, Beijing, China. At least 82 recurrent miscarriage women with a diagnosis of arcuate uterus who had unexplained recurrent spontaneous abortion (less than 12 weeks) before and have fertility requirement will be recruited. The patients will be explained the study and sign the informed consent. According to the random number table, the corresponding cases were divided into treatment group and control group. The experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The follow up of the spontaneous abortion rate and the pregnancy rate of two groups will be screened within 1-2 years and the correlation between the arcuate uterus and recurrent miscarriage will be analyzed.

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Hysteroscopic Centre of Fuxing Hospital
    • Contact: Dongmei Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 3D-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
2. Endometrial pathological diagnosis of chronic endometritis, endometrial hyperplasia and endometrial cancer
3. Ultrasound or HSG suggest hydrosalpinx
4. 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
5. Semen abnormality in male
6. FSH > 10

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hysteroscopic treatment; Hysteroscopic surgery	Procedure: hysteroscopic treatment; treatment
No Intervention: Control group; No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fu Xing Hospital, Capital Medical University
• Investigators: Study Chair: Dongmei Song, Ph.D, Fuxing Hospital, Capital Medical University; Study Director: Tinchiu Li, Ph.D, Prince of Wales Hospital, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: FuXingH02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No