NCT06604091

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,241 (actual)
• Sponsor: The Second Hospital of Shandong University · Academic / Other
• Sex: Female
• Age: 20 Years – 37 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 and ultrasound consensus. Finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice. The detailed inclusion and exclusion criteria are as follows: 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, hydrosalpinx 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 enrolment.

Conditions

• Adenomyosis
• in Vitro Fertilization

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-06-30
• Primary completion: 2027-01-01
• Completion: 2030-01-01
• First posted: 2024-09-19
• Last updated: 2025-08-21

Locations

1 site across 1 country: China