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

NCT ID: NCT02998827

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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thalidomide

use thalidomide tablet by mouth, every night for at least 6 months

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

other treatment

the treatment include infliximab, azathioprine or enteral nutrition at least 6 months

Group Type ACTIVE_COMPARATOR

infliximab, azathioprine

Intervention Type DRUG

other treatment include infliximab, azathioprine

enteral nutrition

Intervention Type OTHER

Interventions

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Thalidomide

Intervention Type DRUG

infliximab, azathioprine

other treatment include infliximab, azathioprine

Intervention Type DRUG

enteral nutrition

Intervention Type OTHER

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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pengxiang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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E2016023

Identifier Type: -

Identifier Source: org_study_id