An interventional study of Thalidomide and infliximab, azathioprine in Crohn Disease, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable and Interventional
The effectiveness of thalidomide in treating inflammatory bowel disease has been widely recognized. Meanwhile, many serious adverse drug reactions were notified， but no reports on ovarian reserve function.Therefore, this study was to investigate the influence of thalidomide on function of ovarian reserve.
It will be divided two groups of patients according to the treatment itself . One group was treated by thalidomide, the other was other treatment excluding. It will detect the function of ovarian reserve before and after treatment in both two groups, to investigate the influence of thalidomide on function of ovarian reserve.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 90 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
use thalidomide tablet by mouth, every night for at least 6 months
Drug: Thalidomide
the treatment include infliximab, azathioprine or enteral nutrition at least 6 months
Drug: infliximab, azathioprine · Other: enteral nutrition
other treatment include infliximab, azathioprine
difference AMH between thalidomide group and other treatment group
Anti-mullerian hormone（AMH）, as an important index to monitor the function of ovarian reserve, is majorly secreted by preantral follicles and antral follicles without fluctuation during menstrual cycle, not affected by hormone, and its change is earlier than sex hormone.
Time frame: 1 year
difference AFC between thalidomide group and other treatment group
The foundational follicles at 5- 10 mm of both ovaries were determined and the sum of antral follicles of both sides of ovaries was as antral follicles communicate (AFC)
Time frame: 1 year
difference E2 between thalidomide group and other treatment group
estradiol，a kind of hormone
Time frame: 1 year
difference FSH between thalidomide group and other treatment group
Follicle stimulating hormone,a kind of hormone
Time frame: 1 year
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Sixth Affiliated Hospital, Sun Yat-sen University