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

Fu Xing Hospital, Capital Medical University

Status: Unknown

Conditions: Arcuate Uterus

Treatments: Procedure: hysteroscopic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03384082

FuXingH02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Hysteroscopic treatment

Experimental group

Description:

Hysteroscopic surgery

Treatment:

Procedure: hysteroscopic treatment

Control group

No Intervention group

Description:

No treatment