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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02998827

Enrollment

Registered

2016-12-20

Start date

2016-11-30

Completion date

Unknown

Last updated

2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

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.

Interventions

DRUGinfliximab, azathioprine

other treatment include infliximab, azathioprine

OTHERenteral nutrition

DRUGThalidomide

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026