Peking University Third Hospital
Beijing, China
Location status: Recruiting
Location contact
Wen Zhang
CONTACT
NCT Number: NCT06123975
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.
Interested in participating?
Request Info18 year–40 year
Female
Observational
Beijing, China
Location status: Recruiting
Wen Zhang
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 10 weeks after embryo transfer
Clinical pregnancy denoted evidence of at least one intrauterine gestational sac observed by ultrasonography 30 days after embryo transfer. Clinical pregnancy rate = Number of patients who achieved clinical pregnancy / Number of transplant cycles.
Time frame: Within 24 weeks after embryo transfer
Miscarriage was defined as the presence of an intrauterine gestational sac but no subsequent live birth after 24 weeks of gestation. Miscarriage rate = Number of patients with miscarriage / Number of patients who achieved clinical pregnancy.
Time frame: Within 1 year after embryo transfer
Live birth was defined as delivery of a live baby after 24 weeks of gestation. Live birth rate = Number of patients with live birth / Number of transplant cycles.
Time frame: Within 12 weeks of gestation
Immune cells and molecules in the peripheral blood on the day of embryo transfer, 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation.
Contact information is provided by the study sponsor or research team.
Peking University Third Hospital
Other
Study of the Role of Immunologic Factors in Adenomyosis Patients With Infertility
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