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Female InfertilityNCT06020924

The Effects of Uterine Fibroids on Pregnancy in Women

An observational study of Female Infertility and Uterine Fibroid, run by Wenwen Wang at 1 site in China.

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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Female Infertility, Uterine Fibroid
How many people
1,658 participants
Where
1 siteChina
Study dates
1 Jun 2023to 31 Dec 2027
Phase
Observational

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
  • Healthy volunteers accepted
  • Adult

Study population: Female patients with uterine fibroids

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Shixuan Wang, PhD, 86-27-83663078, shixuanwang@tjh.tjmu.edu.cn

    Recruiting

Other trials in China

About this study

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.

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.

Being tested
No intervention
Keywords
Infertility, Uterine fibroids, Pregnancy rate
Medical subject headings
Infertility, Female, Leiomyoma, Infertility

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 groups in NCT06020924
Study groupRoleWhat they receive
UFs with infertile patientsUterine fibroids combined with infertile women
Receives: Other: No intervention
UFs with non-infertile patientsUterine 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.

  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.

    Measured: through study completion, an average of 2.5 year

Secondary outcomes (6)
  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.

    Measured: through study completion, an average of 2.5 year

  2. 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.

    Measured: through study completion, an average of 2.5 year

  3. 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.

    Measured: through study completion, an average of 2.5 year

  4. 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.

    Measured: through study completion, an average of 2.5 year

  5. The rate of postpartum hemorrhage varies with different types and size of 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 2.5 year

  6. The rate of malpresentation varies with different types and size of 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 2.5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2023
  2. Study start1 Jun 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Retrospective
Enrolment
1,658 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06020924
Sponsor's protocol ID
UF1.0
Status last verified
Oct 2026
First submitted
22 Jun 2023
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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