Adenomyosis Patients With Infertility and Immunological Factors

NCT ID: NCT06123975

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-10-01

Brief 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.

Detailed 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.

Conditions

Adenomyosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adenomyosis Cohort

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 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.

Venous blood collection

Intervention Type: OTHER

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.

Interventions

Venous blood collection

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients were diagnosed as adenomyosis by transvaginal ultrasound scans (The criteria for sonographic diagnosis of adenomyosis are with 2 or more of the following: heterogeneous myometrial texture with the presence of globular asymmetric uterus, thickening of the anterior and posterior myometrial wall, irregular cystic areas within the myometrium);
• 18≤ age ≤ 40 years old at first outpatient visit in our Reproductive Center;
• with regular menstrual cycle.

Exclusion Criteria

• Patients with intrauterine adhesion, uterine malformation, submucosal leiomyoma, or ≥ 5.0 cm in diameter leiomyoma;
• hydrosalpinx and systemic diseases;
• patients with other endocrine severe diseases, immune diseases, tumors and abnormal chromosomes in either partner.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wen Zhang

Role: CONTACT

chaodongxiehe@163.com

15510659339

Facility Contacts

Wen Zhang

Role: primary

Other Identifiers

LM2021242

Identifier Type: -

Identifier Source: org_study_id