Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06123975 |
Other study ID # |
LM2021242 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2024 |
Est. completion date |
October 1, 2026 |
Study information
Verified date |
August 2023 |
Source |
Peking University Third Hospital |
Contact |
Wen Zhang |
Phone |
15510659339 |
Email |
chaodongxiehe[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Infertile patients with adenomyosis who met the inclusion and exclusion criteria, after
signing the informed consent form, the researchers recorded the clinical information of the
patients and initiated the in vitro fertilization-embryo transfer (IVF-ET) procedure.
Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was
positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after
the transfer and every 2 weeks thereafter until 12 weeks of gestation. By analyzing the
changes of immune cells and molecules in the peripheral blood of the patients, role of immune
factors in infertility combined with adenomyosis was further explored.
Description:
Adenomyosis is a common gynecological disease in women of reproductive age which is
characterized by endometrial glands and stroma in the normal myometrium, accompanied by
hypertrophy of the surrounding myometrial smooth muscle cells.The results of several studies
showed that clinical pregnancy rate and live birth rate of in vitro fertilization-embryo
transfer decreased in infertile patients with adenomyosis. This study intends to explore the
immune-related mechanisms in infertile patients with uterine adenomyosis, with a view to
finding effective clinical intervention targets for adenomyosis associated infertility, and
providing new clues for the prevention and treatment of adenomyosis associated infertility.
Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was
positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after
the transfer and every 2 weeks thereafter until 12 weeks of gestation. The basic
characteristics of the participants, such as age, body mass index, infertility type,
infertility duration, gravida, parity times, basal follicle-stimulating hormone (FSH),
anti-Müllerian hormone, uterine volume before IVF cycle, controlled ovulation
hyperstimulation (COH) protocol, endometrial thickness, number of embryos transferred,
transferred embryo type (cleavage embryo/blastocyst) were evaluated. Pregnancy outcomes of
all patients were followed up. By analyzing the changes of immune cells and molecules in the
peripheral blood of the patients, role of immune factors in infertility combined with
adenomyosis was further explored.