NCT03269916

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 13, 2017

Last Update Submit

August 29, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • The AMH of IBD patients is lower than that of healthy women

    AMH is used to assess ovarian reserve function

    1 month

  • The E2 of IBD patients is lower than that of healthy women

    E2 is used to assess ovarian reserve function

    1 month

  • The FSH of IBD patients is lower than that of healthy women

    FSH is used to assess ovarian reserve function

    1 month

  • The AFC of IBD patients is lower than that of healthy women

    AFC is used to assess ovarian reserve function

    1 month

Study Arms (2)

IBD patients

EXPERIMENTAL

IBD patients, 17-40 years old, female

Other: Anti Mueller hormoneOther: EstrogenOther: Follicle-Stimulating HormoneOther: Antral alveolar cell count

healthy control

OTHER

17-40 years old , female, without any gynecological disease

Other: Anti Mueller hormoneOther: EstrogenOther: Follicle-Stimulating HormoneOther: Antral alveolar cell count

Interventions

used to assess ovarian reserve parameters

IBD patientshealthy control

used to assess ovarian reserve parameters

IBD patientshealthy control

used to assess ovarian reserve parameters

IBD patientshealthy control

used to assess ovarian reserve parameters

IBD patientshealthy control

Eligibility Criteria

Age17 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Inflammatory bowel disease
  • years old
  • female

You may not qualify if:

  • in pregnancy or lactation
  • a drug that has been or is being used known to affect ovarian function, such as cyclophosphamide
  • 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
  • other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine disorders;
  • malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated Hospital of Zhongshan University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

EstrogensFollicle Stimulating Hormone

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesGonadotropins, PituitaryGonadotropinsPeptide HormonesPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Min Zhi, PHD

    The Sixth Affiliated Hospital of Zhongshan University

    STUDY CHAIR

Central Study Contacts

xiang peng, MM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

August 13, 2017

First Posted

September 1, 2017

Study Start

May 1, 2017

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations