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

NCT06604091 | Active Not Recruiting DMC

• 1 other identifier: KYLL2024742
• Study Type: observational
• Target: 2,241
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis; in Vitro Fertilization

Keywords

adenomyosis

Outcome Measures

Primary Outcomes (1)

• cumulative live birth rate

  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.

  from pregnancy to delivery

Secondary Outcomes (5)

• implantation rate

  from transplantation to delivery

• biochemical pregnancy rate

  from transplantation to pregnancy

• ectopic pregnancy rate

  from transplantation to clinical pregnancy

• miscarriage rate

  pregnancy loss before 28 gestational weeks

• clinical pregnancy rate

  pregnancy loss before 28 gestational weeks

Study Arms (4)

Mild adenomyosis group

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

Other: Treatment protocol

Moderate adenomyosis group

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

Other: Treatment protocol

Severe adenomyosis group

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

Other: Treatment protocol

Control group

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

Other: Treatment protocol

Interventions

Treatment protocol 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; Mild adenomyosis group; Moderate adenomyosis group; Severe adenomyosis group

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This trial aims to evaluate the impact of uterine adenomyosis on the pregnancy outcomes of patients undergoing IVF for assisted conception. The study population consists of individuals aged 20-38 years, diagnosed with uterine adenomyosis or general assisted conception patients, diagnosed by ultrasound to meet the MUSA criteria, with a BMI of less than 30 kg/m2, an AMH level of ≥ 0.8 ng/ml, excluding those with uterine fibroids, untreated intrauterine space-occupying lesions, and diseases such as RSA and RIF, and who have not received ICSI and PGT treatments.

You may qualify if:

• Age of all participants ≥ 20 and\< 38 years.
• Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors.
• Conforming to MUSA criteria.
• Body mass index \< 30 kg/m2.
• The level of AMH ≥ 0.8 ng/ml.

You may not qualify if:

• Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids \< 3 cm).
• Untreated endometrial polyps, hydrosalpinges or uterine adhesions.
• RSA or RIF.
• Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
• Concurrent and/or recent involvement in other research within previous 3 months of study

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Clinical Hospital of Shandong University

Jinan, Shandong, 250033, China

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Lin l Cui, M.D., Ph.D.

  The Second Hospital of Shandong University, China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)