Clinical trial NCT06604091: Effect of Adenomyosis on ART Outcomes: a Prospective Cohort Study
Official title: Effects of Adenomyosis on Pregnancy Outcomes in Women With Assisted Reproductive Technology: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenomyosis
in Vitro Fertilization
Keywords: adenomyosis
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 528
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: collect 132 patients in each group

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.

Eligibility criteria: 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

Primary outcomes:
measure: cumulative live birth rate
timeFrame: from pregnancy to delivery
Secondary outcomes:
measure: implantation rate
timeFrame: from transplantation to delivery
measure: biochemical pregnancy rate
timeFrame: from transplantation to pregnancy
measure: ectopic pregnancy rate
timeFrame: from transplantation to clinical pregnancy
measure: miscarriage rate
timeFrame: pregnancy loss before 28 gestational weeks
measure: clinical pregnancy rate
timeFrame: pregnancy loss before 28 gestational weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Second Clinical Hospital of Shandong University
state: Shandong
Study officials:
affiliation: The Second Hospital of Shandong University, China
name: Lin l Cui, M.D., Ph.D.
role: STUDY_CHAIR
References: