Adenomyosis, in Vitro Fertilization
Conditions
Keywords
adenomyosis
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 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.
Interventions
OTHERTreatment protocol
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.
Sponsors
The Second Hospital of Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed