Actively Recruiting

Age: 18Years - 40Years
FEMALE
ID06123975

Study of the Role of Immunologic Factors in Adenomyosis Patients With Infertility

Led by Peking University Third Hospital · Updated on 2024-04-15

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the role of immune factors in infertile women diagnosed with adenomyosis, a condition where endometrial tissue grows into the muscular wall of the uterus. This observational study aims to understand how immune cells and molecules in the blood may affect infertility associated with adenomyosis and to find potential targets for clinical intervention to improve pregnancy outcomes. The study is sponsored by Peking University Third Hospital and follows patients undergoing in vitro fertilization-embryo transfer (IVF-ET). Participants include women aged 18 to 40 with regular menstrual cycles who have adenomyosis diagnosed by specific ultrasound criteria. The study involves collecting peripheral blood on the day of embryo transfer, and if pregnancy is confirmed at 14 days, further blood samples are collected at 21 days and every two weeks thereafter until 12 weeks of gestation. Clinical information such as age, body mass index, infertility details, hormone levels, uterine volume, and embryo transfer characteristics are also recorded. Throughout the study, researchers monitor pregnancy outcomes including clinical pregnancy rate within 10 weeks after embryo transfer, miscarriage rate within 24 weeks, and live birth rate within one year. Secondary measures include analysis of immune cells and molecules in the blood during the first 12 weeks of pregnancy. This involves regular follow-up and blood collection to explore immune changes. The total duration of participation varies depending on pregnancy status and follow-up timing.

CONDITIONS

Brief Title

Adenomyosis Patients With Infertility and Immunological Factors

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with adenomyosis by transvaginal ultrasound showing at least two specific features such as heterogeneous myometrial texture or thickened myometrial walls
  • Female patients aged between 18 and 40 years at the first outpatient visit
  • Regular menstrual cycle
Not Eligible

You will not qualify if you...

  • Presence of intrauterine adhesion, uterine malformation, submucosal leiomyoma, or leiomyoma 5.0 cm or larger in diameter
  • Hydrosalpinx or systemic diseases
  • Severe endocrine diseases, immune diseases, tumors, or abnormal chromosomes in either partner

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 12 weeks of gestation

Participants undergo IVF-ET procedure with peripheral blood collection on the day of embryo transfer and additional blood collections if pregnancy is confirmed to study immune factors related to adenomyosis and infertility.

1 visit on embryo transfer day, then blood collections at 21 days after transfer and every 2 weeks thereafter until 12 weeks of gestation

Long-term Monitoring

Duration - Up to 1 year after embryo transfer

Pregnancy outcomes including clinical pregnancy within 10 weeks, miscarriage within 24 weeks, and live birth within 1 year after embryo transfer are followed up to assess the role of immune factors in infertility associated with adenomyosis.

Follow-up visits as per standard clinical care to monitor pregnancy outcomes

Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, China

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Research Team

W

Wen Zhang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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