Trial Outcomes & Findings for Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions (NCT NCT02708277)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

three years

Results posted on

2016-05-27

Participant Flow

From January 2011 to February 2013, women with severe intrauterine adhesions who presented with a history of infertility were initially included in the study.

Exclusion criteria: endometrial tuberculosis, grossly abnormal semen analysis, ovarian failure, hydrosalpinx fluid, and patients who did not proceed to second-look hysteroscopy within the specified time frame，women with no desire to pregnancy.

Participant milestones

Participant milestones
Measure	Loop-shaped Intrauterine Device Group At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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 Group At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.
Overall Study STARTED	50	43
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Loop-shaped Intrauterine Device Group At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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 Group At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.
Overall Study Lost to Follow-up	7	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=43 Participants At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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.	Group B n=39 Participants At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.3 years STANDARD_DEVIATION 4.3 • n=5 Participants	31.6 years STANDARD_DEVIATION 4.3 • n=7 Participants	31.9 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	43 participants n=5 Participants	39 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: three years

Outcome measures

Outcome measures
Measure	Loop-shaped Intrauterine Device Group n=43 Participants At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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 Group n=39 Participants At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.
Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group	12 participants	22 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Loop-shaped Intrauterine Device Group n=43 Participants At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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 Group n=39 Participants At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.
Menstruation Pattern(Improvement or No Significant Change) of All Participants Menstruation pattern improvement	35 participants	28 participants
Menstruation Pattern(Improvement or No Significant Change) of All Participants Menstruation pattern no significant change	8 participants	11 participants

SECONDARY outcome

Timeframe: Within the first 3 months after surgery

Outcome measures

Outcome measures
Measure	Loop-shaped Intrauterine Device Group n=43 Participants At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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 Group n=39 Participants At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound	6.1 mm Standard Deviation 1.8	6.1 mm Standard Deviation 1.7

SECONDARY outcome

Timeframe: Within the first 3 months after surgery

Outcome measures

Outcome measures
Measure	Loop-shaped Intrauterine Device Group n=43 Participants At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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 Group n=39 Participants At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group Reformation of intrauterine adhesions	16 participants	6 participants
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group Peripheral adhesions	13 participants	4 participants
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group Central adhesions	1 participants	2 participants
Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group Mixed adhesions	2 participants	0 participants

Adverse Events

Loop-shaped Intrauterine Device Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intrauterine Balloon Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Loop-shaped Intrauterine Device Group n=43 participants at risk At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity. loop-shaped intrauterine contraceptive 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 Group n=39 participants at risk At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity. intrauterine balloon (Cook Medical): 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.
Infections and infestations vaginitis	2.3% 1/43 • Number of events 1	2.6% 1/39 • Number of events 1

Additional Information

Yuqing Chen

The First Affiliated Hospital of Sun Yat-sen University

Phone: +86 020-87755766-8341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place