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

NCT ID: NCT06604091

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2030-01-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mild adenomyosis group

disease extent :\< 25% of uterine volume affected by adenomyosis

Treatment protocol

Intervention Type: OTHER

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.

Moderate adenomyosis group

disease extent: 25-50% of uterine volume affected by adenomyosis

Treatment protocol

Intervention Type: OTHER

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.

Severe adenomyosis group

disease extent: \> 50% of uterine volume affected by adenomyosis

Treatment protocol

Intervention Type: OTHER

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.

Control group

Receiving IVF treatment because of common factor, such as fallopian tube factors

Treatment protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Linlin Cui

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

The Second Hospital of Shandong University, China

Locations

The Second Clinical Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

KYLL2024742

Identifier Type: -

Identifier Source: org_study_id