Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel Disease

Fertility Disorders Clinical Trial

Official title:

Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel - a Cross-sectional Survey and Case Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03269916
• Other study ID #: SixthSunYetSen
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2017
• Last updated: August 29, 2017
• Start date: May 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2017
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: xiang peng, MM
• Phone: 18302076916
• Email: stefaniepx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD), because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel disease were almost epidemiological investigation, the lack of objective evaluation of fertility, and controversial.This study will explore the fertility, ovarian reserve function and the pregnancy outcomes in patients with IBD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Inflammatory bowel disease

2. 17-40 years old

3. female

Exclusion Criteria:

1. in pregnancy or lactation

2. a drug that has been or is being used known to affect ovarian function, such as cyclophosphamide

3. reproductive system diseases unrelated to disease or treatment of inflammatory bowel disease, such as hysterectomy, pelvic radiotherapy after surgery, after ovariectomy, polycystic ovary syndrome, endometriosis, ovarian granulosa cell tumor

4. other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine disorders;

5. malignant tumor

Related Conditions & MeSH terms

• Fertility Disorders
• Inflammatory Bowel Diseases
• Ovarian Reserve Function
• Pregnancy Outcomes

Intervention

Other:
• Anti Mueller hormone
used to assess ovarian reserve parameters
• Estrogen
used to assess ovarian reserve parameters
• Follicle-Stimulating Hormone
used to assess ovarian reserve parameters
• Antral alveolar cell count
used to assess ovarian reserve parameters

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of Zhongshan University	GuangZhou	Guangdong

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The AMH of IBD patients is lower than that of healthy women	AMH is used to assess ovarian reserve function	1 month
Primary	The E2 of IBD patients is lower than that of healthy women	E2 is used to assess ovarian reserve function	1 month
Primary	The FSH of IBD patients is lower than that of healthy women	FSH is used to assess ovarian reserve function	1 month
Primary	The AFC of IBD patients is lower than that of healthy women	AFC is used to assess ovarian reserve function	1 month