Uterine FibroidsNCT07177534
Prospective Validation Study of a Uterine Fibroid-Related Infertility Prediction Model
An observational study of Uterine Fibroids and Female Infertility, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids, Female Infertility
- How many people
- 7,084 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Sep 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients with uterine fibroids
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year of unprotected sexual intercourse. Currently, one in six couples is affected by infertility worldwide. With the development of society bringing enormous material and spiritual wealth to human beings, comprehensive factors such as environmental pollution, life and work pressure and bad habits have an important impact on fertility. Infertility is a disease that seriously affects the physical and mental health of patients and brings about serious social problems. According to the World Health Organization (WHO), infertility will become the third major disease in the 21st century following tumor and cardiovascular diseases.
Infertility can be caused by a single factor or multiple factors together. The WHO proposed a classification method based on etiological diagnosis to classify infertility into six major causes: ovulation factors, fallopian tube problems, uterine factors, cervical factors, male factors and psychosocial factors. There is a serious impact on female fertility due to heredity, auto-immunity, infection, metabolic abnormalities, surgery and other factors. The main factors leading to female infertility include patient age, education level, weight (obesity), menstrual history (irregular menstrual cycle), pregnancy history (stillbirth and abortion history), disease history (ovarian cyst, ovarian aging, endocrine autoimmune diseases, fallopian tube abnormalities, pelvic abnormalities and uterine abnormalities), sexual history, previous surgical history, smoking history, chemical exposure history, and mental stress, etc. The objective of this study is to explore the impact of uterine fibroids on female pregnancy rate.
Uterine fibroid is a common benign tumor of female reproductive tract, with 25% to 50% of women of childbearing age suffering from uterine fibroid. The fibroids can cause various clinical symptoms, including menorrhagia, prolonged menstruation, pelvic compression and pain, as well as infertility and obstetric complications, but mostly are asymptomatic. The prevalence of fibroids increases with the age of women, while the fertility rate declines with ages. This complex relationship is particularly harmful. The mechanisms related to fibroids and infertility vary with the type and location of fibroids, including anatomical structure deformation, and interference with the physiological changes of endometrium and implantation of zygotes. In addition, fibroids can destroy the anatomical structure of the pelvis and disrupt the function of the fallopian tube. The FIGO classification describes nine types of fibroids: submucosal fibroids (type 0, Ⅰ, Ⅱ), intramural fibroids (types Ⅲ, Ⅳ, Ⅴ), and subserous fibroids (types Ⅵ and Ⅶ). Among them, submucosal and some intramural fibroids can lead to endometrial inflammatory environment, affecting sperm migration and embryo implantation.
Nevertheless, there is still controversy in epidemiological studies regarding the relationship between uterine fibroids and female infertility. Parity has a significant protective effect against fibroid development, and in fact infertile women may be at higher risk for fibroids. Similarly, it is difficult to distinguish whether fibroids have a direct deleterious effect on infertility, or whether the fibroid-infertility association is mediated by concomitant factors that affect fertility. In addition, the impact of each type of fibroids on fertility varies by the difference in the number, size, and location of fibroids, and the combinations of different fibroids may have special effects. Do uterine fibroids already exist when women plan and attempt to conceive? Do uterine fibroids have negative effects on fertility during this period? It is an urgent need to solve this problem at the present. Therefore, this study is of great significance for us to understand the impact of fibroids on female fertility and guide the treatment patterns of female patients with uterine fibroids who have fertility needs.
- Conditions
- Uterine Fibroids, Female Infertility
- Being tested
- No intervention
- Keywords
- Uterine fibroids, Female Infertility, Pregnancy rate
- Medical subject headings
- Leiomyoma, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study is a retrospective observational study without intervention.
| Study group | Role | What they receive |
|---|---|---|
| UFs with infertile patients | Uterine fibroids combined with infertile women Receives: Other: No intervention | |
| UFs with non-infertile patients | Uterine fibroids combined with non-infertile women Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5 years
Secondary outcomes (6)
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.
Measured: through study completion, an average of 5 years
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.
Measured: through study completion, an average of 5 years
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.
Measured: through study completion, an average of 5 years
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.
Measured: through study completion, an average of 5 years
The rate of postpartum hemorrhage of women with uterine fibroids.
There is an independent association of uterine leiomyomata with increased risk of severe postpartum hemorrhage. Submucosal fibroids are less implicated in bleeding events than intramural and subserosal ones. Great rates of hemorrhage are related with the biggest lesions. The ratio is calculated as the proportion of fibroids combined with postpartum hemorrhage to total patients.
Measured: through study completion, an average of 5 years
The rate of malpresentation of women with uterine fibroids.
Patients with fibroids have an increased risk of breech presentation. Malpresentation may be more related to multiple fibroids an to those bigger than 10 cm. The ratio is calculated as the proportion of fibroids combined with malpresentation to total patients.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7,084 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenwen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177534
- Sponsor's protocol ID
- TJ-UF1.0
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation Study of a Uterine Fibroid-Related Infertility Prediction Model
- ClinicalTrials.gov ID
- NCT07177534
- Acronym / sponsor ID
- TJ-UF1.0
- Conditions
- Uterine Fibroids, Female Infertility
- Keywords
- Uterine fibroids, Female Infertility, Pregnancy rate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,084 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year of unprotected sexual intercourse. Currently, one in six couples is affected by infertility worldwide. With the development of society bringing enormous material and spiritual wealth to human beings, comprehensive factors such as environmental pollution, life and work pressure and bad habits have an important impact on fertility. Infertility is a disease that seriously affects the physical and mental health of patients and brings about serious social problems. According to the World Health Organization (WHO), infertility will become the third major disease in the 21st century following tumor and cardiovascular diseases.
Infertility can be caused by a single factor or multiple factors together. The WHO proposed a classification method based on etiological diagnosis to classify infertility into six major causes: ovulation factors, fallopian tube problems, uterine factors, cervical factors, male factors and psychosocial factors. There is a serious impact on female fertility due to heredity, auto-immunity, infection, metabolic abnormalities, surgery and other factors. The main factors leading to female infertility include patient age, education level, weight (obesity), menstrual history (irregular menstrual cycle), pregnancy history (stillbirth and abortion history), disease history (ovarian cyst, ovarian aging, endocrine autoimmune diseases, fallopian tube abnormalities, pelvic abnormalities and uterine abnormalities), sexual history, previous surgical history, smoking history, chemical exposure history, and mental stress, etc. The objective of this study is to explore the impact of uterine fibroids on female pregnancy rate.
Uterine fibroid is a common benign tumor of female reproductive tract, with 25% to 50% of women of childbearing age suffering from uterine fibroid. The fibroids can cause various clinical symptoms, including menorrhagia, prolonged menstruation, pelvic compression and pain, as well as infertility and obstetric complications, but mostly are asymptomatic. The prevalence of fibroids increases with the age of women, while the fertility rate declines with ages. This complex relationship is particularly harmful. The mechanisms related to fibroids and infertility vary with the type and location of fibroids, including anatomical structure deformation, and interference with the physiological changes of endometrium and implantation of zygotes. In addition, fibroids can destroy the anatomical structure of the pelvis and disrupt the function of the fallopian tube. The FIGO classification describes nine types of fibroids: submucosal fibroids (type 0, Ⅰ, Ⅱ), intramural fibroids (types Ⅲ, Ⅳ, Ⅴ), and subserous fibroids (types Ⅵ and Ⅶ). Among them, submucosal and some intramural fibroids can lead to endometrial inflammatory environment, affecting sperm migration and embryo implantation.
Nevertheless, there is still controversy in epidemiological studies regarding the relationship between uterine fibroids and female infertility. Parity has a significant protective effect against fibroid development, and in fact infertile women may be at higher risk for fibroids. Similarly, it is difficult to distinguish whether fibroids have a direct deleterious effect on infertility, or whether the fibroid-infertility association is mediated by concomitant factors that affect fertility. In addition, the impact of each type of fibroids on fertility varies by the difference in the number, size, and location of fibroids, and the combinations of different fibroids may have special effects. Do uterine fibroids already exist when women plan and attempt to conceive? Do uterine fibroids have negative effects on fertility during this period? It is an urgent need to solve this problem at the present. Therefore, this study is of great significance for us to understand the impact of fibroids on female fertility and guide the treatment patterns of female patients with uterine fibroids who have fertility needs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UFs with infertile patients | – | Other: No interventionUterine fibroids combined with infertile women |
| UFs with non-infertile patients | – | Other: No interventionUterine fibroids combined with non-infertile women |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients with uterine fibroids
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis study is a retrospective observational study without intervention. | Other | UFs with infertile patients, UFs with non-infertile patients |
Primary outcome
The pregnancy rate of women with uterine fibroids.
Time frame: through study completion, an average of 5 years
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.
6 secondary outcomes
The rate of spontaneous abortion of women with uterine fibroids.
Time frame: through study completion, an average of 5 years
The rate of preterm birth of women with uterine fibroids.
Time frame: through study completion, an average of 5 years
The rate of cesarean section of women with uterine fibroids.
Time frame: through study completion, an average of 5 years
The rate of placental abruption of women with uterine fibroids.
Time frame: through study completion, an average of 5 years
The rate of postpartum hemorrhage of women with uterine fibroids.
Time frame: through study completion, an average of 5 years
The rate of malpresentation of women with uterine fibroids.
Time frame: through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids and Female Infertility, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenwen Wang, PhD (+86 15927167698, wenwenwang@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pregnancy rate of women with uterine fibroids. (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.