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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild adenomyosis group | disease extent :< 25% of uterine volume affected by adenomyosis |
| |
| Moderate adenomyosis group | disease extent: 25-50% of uterine volume affected by adenomyosis |
| |
| Severe adenomyosis group | disease extent: > 50% of uterine volume affected by adenomyosis |
| |
| Control group | Receiving IVF treatment because of common factor, such as fallopian tube factors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| implantation rate | IR is the ratio of the total number of gestational sacs confirmed by TVUS to the total number of transferred embryos. | from transplantation to delivery |
| biochemical pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lin l Cui, M.D., Ph.D. | The Second Hospital of Shandong University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Clinical Hospital of Shandong University | Jinan | Shandong | 250033 | China |
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| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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Serum β-hCG level ≥ 10 mIU/mL is defined as biochemical pregnancy.
| from transplantation to pregnancy |
| ectopic pregnancy rate | Ectopic pregnancy is defined as the presence of extra-uterine gestational sacs or masses. | from transplantation to clinical pregnancy |
| miscarriage rate | 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. | pregnancy loss before 28 gestational weeks |
| clinical pregnancy rate | Clinical pregnancy is defined as visible intra-uterine pregnancy or extra-uterine pregnancy. | pregnancy loss before 28 gestational weeks |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |