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Completed

NCT Number: NCT02708277

Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions

The purpose of this study is to compare the outcome of loop intrauterine contraceptive device and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine adhesions in patients with infertility.

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Key information

Conditions

Asherman's Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health. Currently, hysteroscopy is the preferred method of intrauterine adhesions diagnosis and treatment. However, because intrauterine adhesions patients generally have poor endometrium repair capability, the incidence rate of reformation of intrauterine adhesions ranging from 20%-62.5% in those with severe adhesions. The successful pregnancy rate after treatment in severe Asherman's syndrome is reported to be consistently lower, only 33%. The prevention of intrauterine adhesions recurrence after trans-cervical resection of adhesion is clinically important but difficult. Therefore, this study was conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of severe intrauterine adhesions
  • infertility

Exclusion criteria

  • endometrial tuberculosis
  • grossly abnormal semen analysis
  • ovarian failure, hydrosalpinx fluid
  • patients who did not proceed to second-look hysteroscopy within the specified time frame
  • Women with no desire to pregnancy

Treatment and study plan

loop-shaped intrauterine contraceptive device

Device

Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.

intrauterine balloon (Cook Medical)

Device

The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device.

Primary outcomes

  1. Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

    Time frame: three years

Secondary outcomes

  1. Menstruation Pattern(Improvement or No Significant Change) of All Participants

    Time frame: Within the first 3 months after surgery

    Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients

  2. Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

    Time frame: Within the first 3 months after surgery

  3. Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

    Time frame: Within the first 3 months after surgery

Sponsors and collaborators

Lead sponsor

Yuqing Chen

Other

Registry information

Official study title

Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions.

Acronym: ROABTIPWSIUA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2016
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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