Impact of adenomyosis on IVF outcomes

Effects of Adenomyosis on Pregnancy Outcomes in Women With Assisted Reproductive Technology: a Prospective Cohort Study

This study is trying to see how adenomyosis affects pregnancy success rates in women who are going through in vitro fertilization (IVF).

Quick facts

• Study type: Observational
• Enrollment: 528 (estimated)
• Ages: 20 Years to 37 Years
• Sex: Female
• Sponsor: The Second Hospital of Shandong University (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06604091 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the effects of adenomyosis on pregnancy outcomes in women undergoing in vitro fertilization (IVF). It will collect clinical data from infertility patients with adenomyosis, classifying the severity of the condition according to the MUSA criteria. By analyzing these data, the study seeks to clarify how different severities of adenomyosis affect clinical pregnancy rates, live birth rates, and abortion rates. The findings are expected to enhance evidence-based clinical practices for managing infertility in women with adenomyosis.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 20 to 37 who are undergoing IVF treatment due to adenomyosis or male factor infertility.

Not a fit: Patients with significant uterine fibroids, untreated endometrial polyps, or those undergoing specific assisted reproductive technologies like ICSI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights that improve IVF outcomes for women with adenomyosis.

How similar studies have performed: While previous studies have indicated reduced pregnancy outcomes in women with adenomyosis, this study's approach of classifying adenomyosis severity is relatively novel.

Eligibility criteria

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, 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

Where this trial is running

Jinan, Shandong

• The Second Clinical Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Li Ge, M.D., Ph.D.

Conditions: Adenomyosis, in Vitro Fertilization, adenomyosis