Clinical trial NCT03384082: A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri.
Official title: A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri in Women With Recurrent Miscarriage.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arcuate Uterus
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 82
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The pregnancy rate(>12 weeks)of the two groups
timeFrame: 2 years
measure: The spontaneous abortion rate of the two groups
timeFrame: 2 years
measure: The live birth rate of the two groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hysteroscopic Centre of Fuxing Hospital
Study officials:
affiliation: Fuxing Hospital, Capital Medical University
name: Dongmei Song, Ph.D
role: STUDY_CHAIR
affiliation: Prince of Wales Hospital, Chinese University of Hong Kong
name: Tinchiu Li, Ph.D
role: STUDY_DIRECTOR
References: