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NCT Number: NCT07558629

SH-SDU Shandong Endometriosis Reproductive Cohort

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. ...

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Key information

Age range

20 year–37 year

Sex eligibility

Female

Study type

Observational

Primary location

The Second Hospital of Shandong University

Jinan, Shandong, 977998, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. cumulative live birth rate

    Time frame: 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 outcomes

  1. clinical pregnancy rate

    Time frame: from transplantation to clinical pregnancy at 7 weeks

    Clinical pregnancy is defined as visible intra-uterine pregnancy or extra-uterine pregnancy.

  2. miscarriage rate

    Time frame: 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.

  3. ectopic pregnancy rate

    Time frame: from transplantation to clinical pregnancy at 28 weeks

    Ectopic pregnancy is defined as the presence of extra-uterine gestational sacs or masses.

  4. Biochemical pregnancy rate

    Time frame: 14 days after transplant

    The number of biochemical pregnancy cycles divided by the number of transplantation cycles

  5. Pregnancy loss

    Time frame: 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

  6. Stillbirth

    Time frame: 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

  7. Preterm birth

    Time frame: from transplantation to delivery (assessed up to 37 weeks of gestation)

    Delivery before 37 weeks of gestation

  8. Gestational diabetes mellitus

    Time frame: 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

  9. Preeclampsia

    Time frame: 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.

  10. Hypertension in Pregnancy

    Time frame: 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

  11. Premature rupture of membranes

    Time frame: 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

  12. Placenta previa

    Time frame: 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

  13. Placental abruption

    Time frame: 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

  14. Postpartum Hemorrhage

    Time frame: 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

  15. Neonatal death

    Time frame: Within 28 days after birth

    Infants with vital signs at birth die within 28 days after birth

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study title

SH-SDU Shandong Endometriosis Reproductive Cohort: A Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2036
Study completion
2037
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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