A Randomised Controlled Trial of Hysteroscopic Resection... | NCT03384082

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

NCT03384082

Sponsor

Fu Xing Hospital, Capital Medical University

Status

Unknown status

Last Update Posted

Mar 5, 2020Actual

Enrollment

82Estimated

Phase

Not Applicable

Conditions

Arcuate Uterus

Interventions

hysteroscopic treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2019Actual

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Dec 22, 2017

First Posted Date

Dec 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2020

Last Update Posted Date

Mar 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Song Dongmei, Principal Investigator, Fu Xing Hospital, Capital Medical UniversityPrincipal Investigator

Lead Sponsor

Fu Xing Hospital, Capital Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hysteroscopic treatment	Experimental	Hysteroscopic surgery	Procedure: hysteroscopic treatment
Control group	No Intervention	No treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hysteroscopic treatment	Procedure	treatment	Hysteroscopic treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dongmei Song, Ph.D	Contact	88062220		echosdm@163.com
Yu Xiao, Ph.D	Contact

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hysteroscopic Centre of Fuxing Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided