The Effects of Uterine Fibroids on Pregnancy in Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-50
SponsorWenwen Wang
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 20-50 years
Diagnosed with uterine fibroids (by ultrasound or pathology) combined with infertile or non-infertile patients
Complete clinical data.
Disqualifiers
Severe infectious disease or rheumatic immune disease active stage
Previous history of malignant tumors
Incomplete clinical data.
Trial population
Female patients with uterine fibroids
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
No intervention
Other interventionThis study is a retrospective observational study without intervention.
Treatment groups
1,658 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 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.
Time frame
through study completion, an average of 2.5 yearSecondary outcomes
1
The rate of spontaneous abortion varies with different types and size of 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 2.5 year2
The rate of preterm birth varies with different types and size of 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 2.5 year3
The rate of cesarean section varies with different types and size of 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 2.5 year4
The rate of placental abruption varies with different types and size of 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 2.5 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wenwen Wang
Lead sponsor
Tongji Hospital
Sponsor institution
Huazhong University of Science and Technology
Collaborator
Shandong University
Collaborator
Peking University People's Hospital
Collaborator
Source ClinicalTrials.gov