Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora
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|ClinicalTrials.gov Identifier: NCT03731689|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesions||Drug: Intrauterine lavage therapy Drug: Intrauterine gel-injection therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
No Intervention: Control group
Control group( Intrauterine patients) do not apply intrauterine lavage therapy or intrauterine gel-injection therapy after surgery.
Experimental: Intrauterine lavage therapy group
Intrauterine lavage therapy group apply intrauterine lavage therapy after surgery.
Drug: Intrauterine lavage therapy
Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.
Experimental: Intrauterine gel-injection therapy group
Intrauterine gel-injection therapy group apply intrauterine gel-injection therapy after surgery.
Drug: Intrauterine gel-injection therapy
Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.
No Intervention: Healthy control group
Healthy control group 1)have regular menstrual cycles,diagnostic hysteroscopy with endometrial biopsy and laparoscopy as part of their infertility diagnostic work-up prior to IVF, hysteroscopy and subsequent pathological results having shown no abnormality in the uterine cavities and abdominal cavity.2) had male partners who were infertile and diagnosed with defective sperm function,such as asthenozoospermia, oligoasthenozoospermia, severe oligoasthenozoospermia and azoospermia, defined according to guidelines published by the World Health Organization.
- Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound [ Time Frame: 1 year ]
- Menstruation Pattern(Improvement or No Significant Change) of All Participants [ Time Frame: 1 year ]A method similar to visual analogue scale(VAS) was employed for the evaluation of post-operative menstruation with 0 as amenorrhea and 100 as normal menstruation.
- Reduction of American Fertility Society adhesion score at Second-look [ Time Frame: one year ]The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version) . A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 represented severe adhesions.
- Number of Participants With Pregnancy after operation [ Time Frame: two years ]
- Differences in distribution of reproductive tract bacteria between patients are before and after operation [ Time Frame: one year ]
- Differences in distribution of reproductive tract bacteria between healthy control group and intrauterine adhesion patients [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731689
|Contact: Yaling Guo, firstname.lastname@example.org|
|Contact: Yuqing Chen, Deputy email@example.com|
|Principal Investigator:||Yuqing Chen, Deputy chief||First Affiliated Hospital, Sun Yat-Sen University|