Effect of Adenomyosis on ART Outcomes: a Prospective Cohort Study

Recruiting

• Conditions: Adenomyosis; in Vitro Fertilization
• Interventions: Other: Treatment protocol

• Registration Number: NCT06604091
• Lead Sponsor: The Second Hospital of Shandong University

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 simple male factor. 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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 528

Inclusion Criteria

1. Age of all participants ≥ 20 and &lt; 38 years.
2. Receiving IVF treatment because of adenomyosis or simple male factor.
3. Conforming to MUSA criteria.
4. Body mass index &lt; 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 &gt; 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild adenomyosis group	Treatment protocol	disease extent :\< 25% of uterine volume affected by adenomyosis
Moderate adenomyosis group	Treatment protocol	disease extent: 25-50% of uterine volume affected by adenomyosis
Severe adenomyosis group	Treatment protocol	disease extent: \> 50% of uterine volume affected by adenomyosis
Control group	Treatment protocol	infertile patients caused by simple male factor

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
implantation rate	from transplantation to delivery	IR is the ratio of the total number of gestational sacs confirmed by TVUS to the total number of transferred embryos.
biochemical pregnancy rate	from transplantation to pregnancy	Serum β-hCG level ≥ 10 mIU/mL is defined as biochemical pregnancy.
ectopic pregnancy rate	from transplantation to clinical pregnancy	Ectopic pregnancy is defined as the presence of extra-uterine gestational sacs or masses.
miscarriage rate	pregnancy loss before 28 gestational weeks	Miscarriages mean pregnancy loss before 28 gestational weeks. Clinical pregnancy loss ≤ 12 gestational weeks is an early miscarriage, and pregnancy loss between 12 and 28 gestational weeks is a late miscarriage.
clinical pregnancy rate	pregnancy loss before 28 gestational weeks	Clinical pregnancy is defined as visible intra-uterine pregnancy or extra-uterine pregnancy.

Trial Locations

Locations (1)

The Second Clinical Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China