UnknownNot Applicable

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

China82 participantsStarted 2019-02-22

Plain-language 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.

Who can participate

Age range25 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The pregnancy rate(>12 weeks)of the two groups

Timeframe: 2 years

The spontaneous abortion rate of the two groups

Timeframe: 2 years

The live birth rate of the two groups

Timeframe: 2 years

Trial details

NCT IDNCT03384082

SponsorFu Xing Hospital, Capital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-01

Contact for this trial

Dongmei Song, Ph.D

88062220 echosdm@163.com

View on ClinicalTrials.gov More Arcuate Uterus trials

Plain-language summary

Who can participate

Age range25 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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