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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arcuate Uterus

Intervention / Treatment
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* Procedure: hysteroscopic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hysteroscopic treatment<br>Hysteroscopic surgery | Procedure: hysteroscopic treatment<br>* treatment<br>|
| No Intervention: Control group<br>No treatment | |

What is the study measuring?
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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 |