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

August 29, 2017 updated by: pengxiang, Sixth Affiliated Hospital, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510000
        • Recruiting
        • The Sixth Affiliated Hospital of Zhongshan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IBD patients
IBD patients, 17-40 years old, female
Other: Anti Mueller hormone
used to assess ovarian reserve parameters
Other: Estrogen
used to assess ovarian reserve parameters
Other: Follicle-Stimulating Hormone
used to assess ovarian reserve parameters
Other: Antral alveolar cell count
used to assess ovarian reserve parameters
Other: healthy control
17-40 years old , female, without any gynecological disease
Other: Anti Mueller hormone
used to assess ovarian reserve parameters
Other: Estrogen
used to assess ovarian reserve parameters
Other: Follicle-Stimulating Hormone
used to assess ovarian reserve parameters
Other: Antral alveolar cell count
used to assess ovarian reserve parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The AMH of IBD patients is lower than that of healthy women
Time Frame: 1 month
AMH is used to assess ovarian reserve function
1 month
The E2 of IBD patients is lower than that of healthy women
Time Frame: 1 month
E2 is used to assess ovarian reserve function
1 month
The FSH of IBD patients is lower than that of healthy women
Time Frame: 1 month
FSH is used to assess ovarian reserve function
1 month
The AFC of IBD patients is lower than that of healthy women
Time Frame: 1 month
AFC is used to assess ovarian reserve function
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Study Chair: Min Zhi, PHD, The Sixth Affiliated Hospital of Zhongshan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 13, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SixthSunYetSen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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