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

NCT02998827 | Unknown

• 1 other identifier: E2016023
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• difference E2 between thalidomide group and other treatment group

  estradiol，a kind of hormone

  1 year

• difference FSH between thalidomide group and other treatment group

  Follicle stimulating hormone,a kind of hormone

  1 year

Study Arms (2)

thalidomide

EXPERIMENTAL

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

Drug: Thalidomide

other treatment

ACTIVE COMPARATOR

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

Drug: infliximab, azathioprine; Other: enteral nutrition

Interventions

Thalidomide DRUG

thalidomide

infliximab, azathioprine DRUG

other treatment include infliximab, azathioprine

other treatment

enteral nutrition OTHER

other treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-50 years old Diagnosis of patients with CD

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

Thalidomide; Infliximab; Azathioprine; Enteral Nutrition

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 20, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Last Updated: December 20, 2016

Record last verified: 2016-12