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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02998827
• Date of registration: 24/11/2016
• Prospective Registration: No
• Primary sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Public title: Thalidomide Results in Diminished Ovarian Reserve in Reproductive Age Female IBD Patients
• Date of first enrolment: November 2016
• Target sample size: 90
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT02998827
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: N/A

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Other: enteral nutrition

Drug: infliximab, azathioprine

Drug: Thalidomide

Primary Outcome(s)

difference AMH between thalidomide group and other treatment group [Time Frame: 1 year]

difference FSH between thalidomide group and other treatment group [Time Frame: 1 year]

difference E2 between thalidomide group and other treatment group [Time Frame: 1 year]

difference AFC between thalidomide group and other treatment group [Time Frame: 1 year]

Secondary ID(s)

E2016023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors