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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2022-01-01

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.

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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.

Conditions

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Arcuate Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hysteroscopic treatment

Hysteroscopic surgery

Group Type EXPERIMENTAL

hysteroscopic treatment

Intervention Type PROCEDURE

treatment

Control group

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hysteroscopic treatment

treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No