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

Crohn Disease Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02998827
• Other study ID #: E2016023
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 24, 2016
• Last updated: December 19, 2016
• Start date: November 2016

Study information

• Verified date: December 2016
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Thalidomide

• infliximab, azathioprine
other treatment include infliximab, azathioprine

Other:
• enteral nutrition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	difference E2 between thalidomide group and other treatment group	estradiol,a kind of hormone	1 year	Yes
Primary	difference FSH between thalidomide group and other treatment group	Follicle stimulating hormone,a kind of hormone	1 year	Yes