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

Not Applicable

• Conditions: Pregnancy Outcomes; Fertility Disorders; Ovarian Reserve Function
• Interventions: Other: Anti Mueller hormone; Other: Estrogen; Other: Follicle-Stimulating Hormone; Other: Antral alveolar cell count

• Registration Number: NCT03269916
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2017-08
• Study First Submitted: 2017-08-13
• Study First Submitted QC: 2017-08-29
• Last Update Submitted: 2017-08-29
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy control	Anti Mueller hormone	17-40 years old , female, without any gynecological disease
healthy control	Estrogen	17-40 years old , female, without any gynecological disease
healthy control	Follicle-Stimulating Hormone	17-40 years old , female, without any gynecological disease
IBD patients	Follicle-Stimulating Hormone	IBD patients, 17-40 years old, female
IBD patients	Anti Mueller hormone	IBD patients, 17-40 years old, female
IBD patients	Antral alveolar cell count	IBD patients, 17-40 years old, female
IBD patients	Estrogen	IBD patients, 17-40 years old, female
healthy control	Antral alveolar cell count	17-40 years old , female, without any gynecological disease

Primary Outcome Measures

Name	Time	Method
The E2 of IBD patients is lower than that of healthy women	1 month	E2 is used to assess ovarian reserve function
The FSH of IBD patients is lower than that of healthy women	1 month	FSH is used to assess ovarian reserve function
The AFC of IBD patients is lower than that of healthy women	1 month	AFC is used to assess ovarian reserve function
The AMH of IBD patients is lower than that of healthy women	1 month	AMH is used to assess ovarian reserve function

Trial Locations

Locations (1)

The Sixth Affiliated Hospital of Zhongshan University; 🇨🇳 GuangZhou, Guangdong, China