EndometriosisNCT07558629
SH-SDU Shandong Endometriosis Reproductive Cohort
An observational study of Endometriosis and Omics, run by The Second Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Omics, Assisted Reproductive Technology
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2025to Jan 2037
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Mainly composed of people from Shandong Province
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SH-SDU Shandong Endometriosis Reproductive Cohort: A Prospective Cohort Study
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
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from transplantation to live birth at 1 year
Secondary outcomes (15)
clinical pregnancy rate
Clinical pregnancy is defined as visible intra-uterine pregnancy or extra-uterine pregnancy.
Measured: from transplantation to clinical pregnancy at 7 weeks
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.
Measured: pregnancy loss before 28 gestational weeks
ectopic pregnancy rate
Ectopic pregnancy is defined as the presence of extra-uterine gestational sacs or masses.
Measured: from transplantation to clinical pregnancy at 28 weeks
Biochemical pregnancy rate
The number of biochemical pregnancy cycles divided by the number of transplantation cycles
Measured: 14 days after transplant
Pregnancy loss
Natural termination of clinical pregnancy or therapeutic induction of labor before 28 weeks of gestation
Measured: from transplantation to abortion (assessed up to 28 weeks of gestation)
Stillbirth
A baby without vital signs is delivered at 28 weeks or more of gestation
Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)
Preterm birth
Delivery before 37 weeks of gestation
Measured: from transplantation to delivery (assessed up to 37 weeks of gestation)
Gestational diabetes mellitus
Abnormalities of glucose metabolism of different degrees that first occur and are discovered during pregnancy
Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)
Preeclampsia
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.
Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)
Hypertension in Pregnancy
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
Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)
Premature rupture of membranes
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
Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)
Placenta previa
The lower edge of the placenta is adjacent to or covers the internal OS of the cervix
Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)
Placental abruption
The placenta in its normal position partially or completely separates from the uterine wall before the fetus is delivered
Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)
Postpartum Hemorrhage
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
Measured: Within 24 hours after childbirth
Neonatal death
Infants with vital signs at birth die within 28 days after birth
Measured: Within 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start14 Oct 2025
- Primary completionJan 2036 (estimated)
- Study completionJan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558629
- Sponsor's protocol ID
- KYLL202509670
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SH-SDU Shandong Endometriosis Reproductive Cohort: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07558629
- Acronym / sponsor ID
- KYLL202509670
- Conditions
- Endometriosis, Omics, Assisted Reproductive Technology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Jan 2036 (estimated)
- Study completion
- Jan 2037 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. ...
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mainly composed of people from Shandong Province
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
15 secondary outcomes
clinical pregnancy rate
Time frame: from transplantation to clinical pregnancy at 7 weeks
miscarriage rate
Time frame: pregnancy loss before 28 gestational weeks
ectopic pregnancy rate
Time frame: from transplantation to clinical pregnancy at 28 weeks
Biochemical pregnancy rate
Time frame: 14 days after transplant
Pregnancy loss
Time frame: from transplantation to abortion (assessed up to 28 weeks of gestation)
Stillbirth
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
Preterm birth
Time frame: from transplantation to delivery (assessed up to 37 weeks of gestation)
Gestational diabetes mellitus
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
Preeclampsia
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
Hypertension in Pregnancy
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
Premature rupture of membranes
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
Placenta previa
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
Placental abruption
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
Postpartum Hemorrhage
Time frame: Within 24 hours after childbirth
Neonatal death
Time frame: Within 28 days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Omics, run by The Second Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative live birth rate (time frame: from transplantation to live birth at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.