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

Arcuate Uterus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03384082
• Other study ID #: FuXingH02
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2020
• Source: Fu Xing Hospital, Capital Medical University
• Contact: Dongmei Song, Ph.D
• Phone: 88062220
• Email: echosdm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Arcuate Uterus

Intervention

Procedure:
• hysteroscopic treatment
treatment

Locations

Country	Name	City	State
China	Hysteroscopic Centre of Fuxing Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Xing Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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