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

The Second Hospital of Shandong University

Status: Active, not recruiting

Conditions: in Vitro Fertilization; Adenomyosis

Treatments: Other: Treatment protocol

Study type: Observational

Funder types: Other

Identifiers

NCT06604091

KYLL2024742

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,241 patients

Sex: Female

Ages: 20 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,241 participants in 4 patient groups

Mild adenomyosis group

Description:

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

Treatment:

Other: Treatment protocol

Moderate adenomyosis group

Description:

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

Treatment:

Other: Treatment protocol

Severe adenomyosis group

Description:

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

Treatment:

Other: Treatment protocol

Control group

Description:

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

Treatment:

Other: Treatment protocol