Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: Thalidomide
* Drug: infliximab, azathioprine
* Other: enteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50 years old Diagnosis of patients with CD Exclusion Criteria: Pregnancy or lactation Period of women have fertility program during the study Treatment not foot eight weeks after last IFX Central or peripheral nerve disease Abnormal in liver and renal function Heart function failure Malignant tumor Active tuberculosis
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thalidomide<br>use thalidomide tablet by mouth, every night for at least 6 months | Drug: Thalidomide<br> <br> |
| Active Comparator: other treatment<br>the treatment include infliximab, azathioprine or enteral nutrition at least 6 months | Drug: infliximab, azathioprine<br>* other treatment include infliximab, azathioprine<br>Other: enteral nutrition<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 1 year | 
| difference E2 between thalidomide group and other treatment group | estradiol，a kind of hormone | 1 year | 
| difference FSH between thalidomide group and other treatment group | Follicle stimulating hormone,a kind of hormone | 1 year |