SH-SDU Shandong Endometriosis Reproductive Cohort

NCT07558629 | Active Not Recruiting DMC

• 1 other identifier: KYLL202509670
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Endometriosis; Omics; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (1)

• 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 transplantation to live birth at 1 year

Secondary Outcomes (15)

• clinical pregnancy rate

  from transplantation to clinical pregnancy at 7 weeks

• miscarriage rate

  pregnancy loss before 28 gestational weeks

• ectopic pregnancy rate

  from transplantation to clinical pregnancy at 28 weeks

• Biochemical pregnancy rate

  14 days after transplant

• Pregnancy loss

  from transplantation to abortion (assessed up to 28 weeks of gestation)

Study Arms (2)

Control group

Receiving IVF treatment because of common factor, such as fallopian tube factors

Endometriosis group

Patients diagnosed with endometriosis through surgery, ultrasound or magnetic resonance imaging

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mainly composed of people from Shandong Province

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 977998, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood, urine, follicular fluid, endometrium, semen, umbilical cord blood, placental tissue

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: April 30, 2026
• Study Start: October 14, 2025
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2037
• Last Updated: April 30, 2026

Record last verified: 2026-02

Locations

CN (1)