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

Not Applicable

• Conditions: Crohn Disease
• Interventions: Drug: Thalidomide; Drug: infliximab, azathioprine; Other: enteral nutrition

• Registration Number: NCT02998827
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-24
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Study First Posted: 2016-12-20
• Last Update Posted: 2016-12-20
• Primary Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Age 18-50 years old Diagnosis of patients with CD

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thalidomide	Thalidomide	use thalidomide tablet by mouth, every night for at least 6 months
other treatment	infliximab, azathioprine	the treatment include infliximab, azathioprine or enteral nutrition at least 6 months
other treatment	enteral nutrition	the treatment include infliximab, azathioprine or enteral nutrition at least 6 months

Primary Outcome Measures

Name	Time	Method
difference AMH between thalidomide group and other treatment group	1 year	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.
difference AFC between thalidomide group and other treatment group	1 year	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)
difference FSH between thalidomide group and other treatment group	1 year	Follicle stimulating hormone,a kind of hormone
difference E2 between thalidomide group and other treatment group	1 year	estradiol，a kind of hormone