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

Sun Yat-sen University

Status: Unknown

Conditions: Crohn Disease

Treatments: Other: enteral nutrition; Drug: infliximab, azathioprine; Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02998827

E2016023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

90 participants in 2 patient groups

thalidomide

Experimental group

Description:

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

Treatment:

Drug: Thalidomide

other treatment

Active Comparator group

Description:

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

Treatment:

Drug: infliximab, azathioprine

Other: enteral nutrition