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Search / Trial NCT06604091

Effect of Adenomyosis on ART Outcomes: a Prospective Cohort Study

Launched by THE SECOND HOSPITAL OF SHANDONG UNIVERSITY · Sep 17, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Adenomyosis

ClinConnect Summary

This clinical trial is studying how adenomyosis, a condition where the tissue that normally lines the uterus grows into the uterine wall, affects the success of in vitro fertilization (IVF). Previous research has suggested that women with adenomyosis may have lower chances of getting pregnant and higher rates of miscarriage compared to those without the condition. However, many of these studies didn’t clearly define the severity of adenomyosis, which makes it hard to understand its true impact on pregnancy outcomes. This research aims to collect detailed information from women with adenomyosis who are undergoing IVF, using a specific classification system to better understand how different severities of adenomyosis influence their chances of a successful pregnancy.

To be eligible for the trial, participants need to be women aged between 20 and 38 who are seeking IVF treatment due to adenomyosis or a male fertility factor. They should also have a healthy body weight and certain hormone levels. However, women with other significant uterine conditions or those currently involved in other research studies are not eligible. Participants can expect to provide clinical data related to their condition during the study, which will help improve understanding and treatment options for women facing similar challenges in the future.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age of all participants ≥ 20 and \< 38 years.
  • 2. Receiving IVF treatment because of adenomyosis or simple male factor.
  • 3. Conforming to MUSA criteria.
  • 4. Body mass index \< 30 kg/m2.
  • 5. The level of AMH ≥ 0.8 ng/ml.
  • Exclusion Criteria:
  • 1. Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids \> 3 cm).
  • 2. Untreated endometrial polyps, hydrosalpinges or uterine adhesions.
  • 3. RSA or RIF.
  • 4. Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
  • 5. Concurrent and/or recent involvement in other research within previous 3 months of study

About The Second Hospital Of Shandong University

The Second Hospital of Shandong University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to improving patient outcomes by exploring new therapeutic interventions and enhancing existing treatment protocols. With a multidisciplinary approach and a robust infrastructure, the institution facilitates rigorous scientific inquiry while adhering to the highest ethical standards. The Second Hospital of Shandong University actively collaborates with researchers and healthcare professionals to contribute to the global body of medical knowledge and to ensure the delivery of safe and effective care to patients.

Locations

Jinan, Shandong, China

Patients applied

0 patients applied

Trial Officials

Lin l Cui, M.D., Ph.D.

Study Chair

The Second Hospital of Shandong University, China

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported