The Effects of Uterine Fibroids on Pregnancy in Women

NCT06020924 | Unknown

• 1 other identifier: UF1.0
• Study Type: observational
• Target: 1,658
• Locations: 1 country
• Sites: 1

Brief Summary

Female fertility may be affected by uterine fibroids, although this association has not been elucidated. This retrospective cohort study aims to evaluate the impact of fibroids on women fertility.

Conditions

Female Infertility; Uterine Fibroid

Keywords

Infertility; Uterine fibroids; Pregnancy rate

Outcome Measures

Primary Outcomes (1)

• The pregnancy rate varies with different types and size of fibroids.

  Fibroid types range from 0 to 8 according to the FIGO classification. The pregnancy rate varies with different types and size of fibroids. Subserosal fibroids do not exert any detrimental effects on fertility outcomes. Submucosal fibroids have negatively impact fertility. The effect of intramural fibroids on reproductive outcome has been a subject of debate in the past, but recent literature indicates that intramural myomas also negative impact fertility.

  through study completion, an average of 2.5 year

Secondary Outcomes (6)

• The rate of spontaneous abortion varies with different types and size of fibroids.

  through study completion, an average of 2.5 year

• The rate of preterm birth varies with different types and size of fibroids.

  through study completion, an average of 2.5 year

• The rate of cesarean section varies with different types and size of fibroids.

  through study completion, an average of 2.5 year

• The rate of placental abruption varies with different types and size of fibroids.

  through study completion, an average of 2.5 year

• The rate of postpartum hemorrhage varies with different types and size of fibroids.

  through study completion, an average of 2.5 year

Study Arms (2)

UFs with infertile patients

Uterine fibroids combined with infertile women

Other: No intervention

UFs with non-infertile patients

Uterine fibroids combined with non-infertile women

Other: No intervention

Interventions

No intervention OTHER

This study is a retrospective observational study without intervention.

UFs with infertile patients; UFs with non-infertile patients

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with uterine fibroids

You may qualify if:

• Age: 20-50 years
• Diagnosed with uterine fibroids (by ultrasound or pathology) combined with infertile or non-infertile patients
• Complete clinical data.

You may not qualify if:

• Severe infectious disease or rheumatic immune disease active stage
• Previous history of malignant tumors
• Incomplete clinical data.

Sponsors & Collaborators

• Wenwen Wang: lead
• Huazhong University of Science and Technology: collaborator
• Shandong University: collaborator
• Peking University People's Hospital: collaborator

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Leiomyoma; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Shixuan Wang

  Huazhong University of Science and Technology, Wuhan, Hubei, China, 430000

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shixuan Wang

CONTACT

86-27-83663078; shixuanwang@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: September 1, 2023
• Study Start: August 31, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)