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Active, not recruiting Observational

Cohort Profile:The Shandong Adenomyosis Cohort of Population Undergoing Reproductive Technology (SAart)

NCT06604091 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-06-30
Last updated
2025-08-21

Condition(s) studied

Adenomyosisin Vitro Fertilization

Investigational drug(s) / intervention(s)

Treatment protocol

Treatment protocol: Treatment options for ovarian stimulation include long-acting and antagonist regimens and other ovulation induction regimens. Options for frozen embryo transfer include natural protocols, mild ovarian stimulation regimens, hormone replacement therapy (HRT) regimens, and down-regulated combined HRT regimens. The treatment regimen is refined in the above protocol. The treatment of patients follows the principles of real-world clinical practice.

Study summary

Previous studies have shown that compared with infertile women without adenomyosis, the clinical pregnancy rate, live birth rate and continuous pregnancy rate of women with adenomyosis significantly reduce, and the abortion rate obviously increased. However, these studies lack a definite classification of adenomyosis, so the true effect of adenomyosis with different severity on pregnancy outcomes are not clear. Our research team intends to collect clinical data of infertility patients with adenomyosis receiving IVF and the detailed classification of adenomyosis according to MUSA criteria. Finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
37 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age of all participants ≥ 20 and\< 38 years. 2. Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors. 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

Primary outcome measure(s)

  • cumulative live birth rate — from pregnancy to delivery
    The numerator is number of live births from fresh or frozen embryo transfer in one ovarian stimulation cycle. More than one live birth is considered as one live birth. Denominator is defined as patients who have undergone oocyte retrieval and have either achieved at least one live birth or who have no surplus embryos.

Trial sites (1)

FacilityCityRegionStatus
The Second Clinical Hospital of Shandong University Jinan Shandong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06604091 on ClinicalTrials.gov ↗ ← All trials in China