Adenomyosis Patients With Infertility and Immunological Factors

Recruiting

• Conditions: Adenomyosis
• Interventions: Other: Venous blood collection

• Registration Number: NCT06123975
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-09
• Study Start: 2024-03-01
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adenomyosis Cohort	Venous blood collection	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.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	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.
Live birth rate	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.
Miscarriage rate	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.

Secondary Outcome Measures

Name	Time	Method
Immune cells and molecules in the peripheral blood	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China