Prospective Validation Study of a Uterine Fibroid-Related Infertility Prediction Model
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-50
SponsorTongji Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Female patients with uterine fibroids
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionThis study is a retrospective observational study without intervention.
Treatment groups
7,084 Participants
are divided into 2 treatment groupsGroup A: UFs with infertile patients1 intervention
Group B: UFs with non-infertile patients1 intervention
Trial outcomes
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.
Time frame
through study completion, an average of 5 yearsSecondary outcomes
1
The rate of spontaneous abortion of women with uterine fibroids.
Fibroids are a source of several obstetric complications, including spontaneous abortion, preterm birth, cesarean section, placental abruption, postpartum hemorrhage, and breech presentation. Submucosal fibroids and multiple myomas have an increased risk of miscarriage. The rate is calculated as the proportion of the number of miscarriage to the total number of pregnancies in different types of fibroids.
Time frame
through study completion, an average of 5 years2
The rate of preterm birth of women with uterine fibroids.
Fibroids measuring more than 5 centimetre (cm) have been linked to delivery at earlier gestational age. The ratio is calculated as the proportion of fibroids combined with preterm birth to fibroids combined with live birth.
Time frame
through study completion, an average of 5 years3
The rate of cesarean section of women with uterine fibroids.
Greater size and number of fibroids were associated with increased incidence of cesarean delivery. The ratio is calculated as the proportion of fibroids combined with cesarean section to total births.
Time frame
through study completion, an average of 5 years4
The rate of placental abruption of women with uterine fibroids.
Fibroids have an increased risk of placental abruption in patients. The ratio is calculated as the proportion of fibroids combined with placental abruption to total patients.
Time frame
through study completion, an average of 5 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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