Clinical trial NCT06123975: Adenomyosis Patients With Infertility and Immunological Factors
Official title: Study of the Role of Immunologic Factors in Adenomyosis Patients With Infertility
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenomyosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile patients with adenomyosis who underwent IVF-ET at the Reproductive Center of the 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.

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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: Within 10 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: Within 24 weeks after embryo transfer
measure: Live birth rate
timeFrame: Within 1 year after embryo transfer
Secondary outcomes:
measure: Immune cells and molecules in the peripheral blood
timeFrame: Within 12 weeks of gestation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Wen Zhang
role: PRINCIPAL_INVESTIGATOR
References: