Assisted Reproductive Technology, Endometriosis, Omics
Conditions
Brief summary
Endometriosis (EMs) is a chronic, estrogen-dependent, multi-systemic disease that affects approximately 190 million women worldwide. EMs can increase the risk of miscarriage, and even mild EMs can negatively affect fertilization and implantation rates. Some meta-analyses have reported that EMs increases the risk of adverse obstetric outcomes, such as preterm birth and cesarean section, and also increases the risk of neonatal hospitalization. In addition to affecting pregnancy outcomes in women of reproductive age, EMs has significant social and psychological impacts on women of all ages in multiple areas of life, and can further affect the entire family, leading to substantial economic burdens and reduced quality of life. Finally, due to the increased incidence of the disease in the offspring of EMs patients, long-term follow-up is also a key aspect of disease management. To improve clinical practice and enhance fertility in EMs patients, more evidence is needed to meet the key priorities of future research. Integrated analysis of comprehensive case resources and clinical data can provide a reliable research foundation for future personalized diagnosis and treatment. High-quality and traceable large biobanks are a crucial resource for exploring pathogenic mechanisms. Prospective cohort studies conducted on this basis are expected to investigate the impact of the disease on patient clinical outcomes and further explore the disease's pathogenesis, aiming to identify physiological pathways influenced by the epigenome, transcriptome, proteome, and metabolome. ...
Interventions
None listed
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
Yes
Inclusion criteria
* Patients with endometriosis and non-endometriosis who are scheduled to undergo in vitro fertilization/ intracytoplasmic sperm injection treatment at our hospital; * Womens' age \<38 year; * Patients diagnosed with endometriosis through surgery, ultrasound or magnetic resonance imaging.
Exclusion criteria
* The patient suffers from a severe uterine leiomyoma or other serious diseases; * The patient previously underwent unilateral/bilateral oophorectomy due to the disease; * The patient was previously diagnosed with a tumor-related disease; * The patients with immune disorders or metabolic diseases; * The patient undergoes egg cell donation; * The patient underwent pre-implantation genetic diagnosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative live birth rate | from transplantation to live birth at 1 year | 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 |
|---|---|---|
| clinical pregnancy rate | from transplantation to clinical pregnancy at 7 weeks | Clinical pregnancy is defined as visible intra-uterine pregnancy or extra-uterine pregnancy. |
| 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. |
| ectopic pregnancy rate | from transplantation to clinical pregnancy at 28 weeks | Ectopic pregnancy is defined as the presence of extra-uterine gestational sacs or masses. |
| Biochemical pregnancy rate | 14 days after transplant | The number of biochemical pregnancy cycles divided by the number of transplantation cycles |
| Pregnancy loss | from transplantation to abortion (assessed up to 28 weeks of gestation) | Natural termination of clinical pregnancy or therapeutic induction of labor before 28 weeks of gestation |
| Stillbirth | from transplantation to delivery (assessed up to 40 weeks of gestation) | A baby without vital signs is delivered at 28 weeks or more of gestation |
| Preterm birth | from transplantation to delivery (assessed up to 37 weeks of gestation) | Delivery before 37 weeks of gestation |
| Gestational diabetes mellitus | from transplantation to delivery (assessed up to 40 weeks of gestation) | Abnormalities of glucose metabolism of different degrees that first occur and are discovered during pregnancy |
| Preeclampsia | from transplantation to delivery (assessed up to 40 weeks of gestation) | After 20 weeks of gestation, if a pregnant woman has a systolic blood pressure of ≥140 mmHg and/or a diastolic blood pressure of ≥90 mmHg, accompanied by any one of the following: urine protein quantification ≥0.3 g/24 h, or the urine protein/creatinine ratio ≥0.3, or random urine protein ≥(+)(the examination method when protein quantification is not performed unconditionally); There is no proteinuria but any one of the following organs or systems is involved: important organs such as the heart, lungs, liver, and kidneys, or abnormal changes in the blood system, digestive system, and nervous system, or the placenta and fetus are involved, etc. |
| Hypertension in Pregnancy | from transplantation to delivery (assessed up to 40 weeks of gestation) | Hypertension first occurred after 20 weeks of pregnancy, with a systolic blood pressure of ≥140 mmHg (1 mmHg=0.133 kPa) and/or a diastolic blood pressure of ≥90 mmHg; The urine protein test was negative |
| Premature rupture of membranes | from transplantation to delivery (assessed up to 40 weeks of gestation) | It refers to the spontaneous rupture of the fetal membranes before labor. According to the gestational age at which it occurs, it is divided into full-term fetal membranes and preterm premature rupture of fetal membranes |
| Placenta previa | from transplantation to delivery (assessed up to 40 weeks of gestation) | The lower edge of the placenta is adjacent to or covers the internal OS of the cervix |
| Placental abruption | from transplantation to delivery (assessed up to 40 weeks of gestation) | The placenta in its normal position partially or completely separates from the uterine wall before the fetus is delivered |
| Postpartum Hemorrhage | Within 24 hours after childbirth | Within 24 hours after the delivery of the fetus, the amount of blood loss in parturients with vaginal delivery is ≥500 ml, the amount of blood loss in parturients with cesarean section is ≥ 1,000 ml, or there are symptoms or signs of hypovolume after blood loss |
| Neonatal death | Within 28 days after birth | Infants with vital signs at birth die within 28 days after birth |
Countries
China
Outcome results
None listed