The Prevalence and Reproductive Outcome of Infertile Women With Genital Tuberculosis

Summary

Female genital tuberculosis infection (FGTB) is an important cause of female infertility in TB-endemic areas. The pregnancy rate of assisted reproductive treatment (ART) in the infertile women with FGTB is still unsatisfied even after receiving standard anti-tuberculosis treatment. Moreover, recent years have witnessed an alarming increase in reports of FGTB-related maternal and neonatal complications after fertility treatments. These underscore that timely detection and treatment of FGTB before ART hold benefit for the mother and child.

Conditions

• Infertility, Female
• Genital Tuberculoses, Female

Interventions

DIAGNOSTIC_TEST

QuantiFERON-TB test & endometrial pathology & endometrial tissue GeneXpert Ultra

Endometrial biopsy is required to diagnose LTBI, SGTB and FGTB, which is an invasive operation and increases patients' economic burden. A screening method has been established that uses the interferon gamma release test as the primary screening test, and those who are positive undergo endometrial biopsy. Therefore, this project will use QFT to screen participants with Mtb infection, and further endometrium biopsy will be performed for QFT positive patients to diagnose LTBI, FGTB and SGTB. For participants with negative results for all diagnostic tests but QFT (defined as LTBI), close follow-up is necessary according to WHO guidelines.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The 924th Hospital of Joint Logistics Support Force of Chinese People's Liberation

  collaborator UNKNOWN

• Shenzhen Zhongshan Urology Hospita

  collaborator UNKNOWN

• Northwest Women's and Children's Hospital, Xi'an, Shaanxi

  collaborator OTHER

• Jiangxi Maternal and Child Health Hospital

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Huashan Hospital

  lead OTHER

Eligibility

Min Age

20 Years

Max Age

43 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2023-06-01

Completion

2023-08-01

Countries

• China

Study Locations