Prospective Validation Study of a Uterine Fibroid-Related Infertility Prediction Model

NCT07177534 | Not Yet Recruiting DMC

• 1 other identifier: TJ-UF1.0
• Study Type: observational
• Target: 7,084
• Locations: 0 countries
• Sites: N/A

Brief Summary

Female fertility may be affected by uterine fibroids, although this association has not been elucidated. Our retrospective study has already constructed a predictive model for infertility risk in patients with uterine fibroids using machine learning. We will now validate and optimize this model through a prospective study

Conditions

Uterine Fibroids; Female Infertility

Keywords

Uterine fibroids; Female Infertility; Pregnancy rate

Outcome Measures

Primary Outcomes (1)

• The pregnancy rate of women with uterine 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.The pregnancy rate among patients with uterine fibroids is calculated as the proportion of those who achieve pregnancy relative to the total number of patients with uterine fibroids.

  through study completion, an average of 5 years

Secondary Outcomes (6)

• The rate of spontaneous abortion of women with uterine fibroids.

  through study completion, an average of 5 years

• The rate of preterm birth of women with uterine fibroids.

  through study completion, an average of 5 years

• The rate of cesarean section of women with uterine fibroids.

  through study completion, an average of 5 years

• The rate of placental abruption of women with uterine fibroids.

  through study completion, an average of 5 years

• The rate of postpartum hemorrhage of women with uterine fibroids.

  through study completion, an average of 5 years

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: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with uterine fibroids

You may qualify if:

• Women aged 20-50 years with recent desires for conception. Diagnosed with uterine fibroids via ultrasound or pathology. Complete clinical records available. Ability to provide informed consent.

You may not qualify if:

• Active severe infectious or rheumatologic autoimmune diseases. History of malignant tumors. Incomplete clinical records. Unable to contact via phone or refusal to participate in follow-up.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Leiomyoma; Infertility, Female

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wenwen Wang, PhD

CONTACT

+86 15927167698; wenwenwang@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 17, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: September 17, 2025

Record last verified: 2025-09