Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06020924 |
| Other study ID # |
UF1.0 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 31, 2023 |
| Est. completion date |
November 30, 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Tongji Hospital |
| Contact |
Shixuan Wang |
| Phone |
86-27-83663078 |
| Email |
shixuanwang[@]tjh.tjmu.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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