AdenomyosisNCT06604091
Cohort Profile：The Shandong Adenomyosis Cohort of Population Undergoing Reproductive Technology (SAart)
An observational study of Adenomyosis and in Vitro Fertilization, run by The Second Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Adenomyosis, in Vitro Fertilization
- What is being tested?
- Treatment protocol
- How many people
- 2,241 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 1 Jan 2030
- 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
- No healthy volunteers
- Adult
Study population: This trial aims to evaluate the impact of uterine adenomyosis on the pregnancy outcomes of patients undergoing IVF for assisted conception. The study population consists of individuals aged 20-38 years, diagnosed with uterine adenomyosis or general assisted conception patients, diagnosed by ultrasound to meet the MUSA criteria, with a BMI of less than 30 kg/m2, an AMH level of ≥ 0.8 ng/ml, excluding those with uterine fibroids, untreated intrauterine space-occupying lesions, and diseases such as RSA and RIF, and who have not received ICSI and PGT treatments.
Who may be able to join
- Age of all participants ≥ 20 and< 38 years.
- Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors.
- Conforming to MUSA criteria.
- Body mass index < 30 kg/m2.
- The level of AMH ≥ 0.8 ng/ml.
Who cannot join
- Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids < 3 cm).
- Untreated endometrial polyps, hydrosalpinges or uterine adhesions.
- RSA or RIF.
- Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
- Concurrent and/or recent involvement in other research within previous 3 months of study
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Clinical Hospital of Shandong University
Jinan, Shandong, 250033
About this study
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.
Read the 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
- Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids > 3 cm).
- Untreated endometrial polyps, hydrosalpinx or uterine adhesions.
- RSA or RIF.
- Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
- Concurrent and/or recent involvement in other research within previous 3 months of study enrolment.
- Conditions
- Adenomyosis, in Vitro Fertilization
- Being tested
- Treatment protocol
- Keywords
- adenomyosis
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild adenomyosis group | disease extent :< 25% of uterine volume affected by adenomyosis Receives: Other: Treatment protocol | |
| Moderate adenomyosis group | disease extent: 25-50% of uterine volume affected by adenomyosis Receives: Other: Treatment protocol | |
| Severe adenomyosis group | disease extent: > 50% of uterine volume affected by adenomyosis Receives: Other: Treatment protocol | |
| Control group | Receiving IVF treatment because of common factor, such as fallopian tube factors Receives: Other: Treatment protocol |
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 pregnancy to delivery
Secondary outcomes (5)
implantation rate
IR is the ratio of the total number of gestational sacs confirmed by TVUS to the total number of transferred embryos.
Measured: from transplantation to delivery
biochemical pregnancy rate
Serum β-hCG level ≥ 10 mIU/mL is defined as biochemical pregnancy.
Measured: from transplantation to pregnancy
ectopic pregnancy rate
Ectopic pregnancy is defined as the presence of extra-uterine gestational sacs or masses.
Measured: from transplantation to clinical pregnancy
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
clinical pregnancy rate
Clinical pregnancy is defined as visible intra-uterine pregnancy or extra-uterine pregnancy.
Measured: pregnancy loss before 28 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Jun 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies 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
- 2,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linlin Cui, The Second Hospital of Shandong University
- Investigators
- Lin l Cui, M.D., Ph.D., Study chair, The Second Hospital of Shandong University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604091
- Sponsor's protocol ID
- KYLL2024742
- Status last verified
- Aug 2025
- First submitted
- 17 Sep 2024
- Last updated
- 21 Aug 2025
- 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Profile：The Shandong Adenomyosis Cohort of Population Undergoing Reproductive Technology (SAart)
- ClinicalTrials.gov ID
- NCT06604091
- Acronym / sponsor ID
- KYLL2024742
- Conditions
- Adenomyosis, in Vitro Fertilization
- Keywords
- adenomyosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,241 participants (actual)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 19 Sep 2024 (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.
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
- Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids > 3 cm).
- Untreated endometrial polyps, hydrosalpinx or uterine adhesions.
- RSA or RIF.
- Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
- Concurrent and/or recent involvement in other research within previous 3 months of study enrolment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild adenomyosis group | – | Other: Treatment protocoldisease extent :< 25% of uterine volume affected by adenomyosis |
| Moderate adenomyosis group | – | Other: Treatment protocoldisease extent: 25-50% of uterine volume affected by adenomyosis |
| Severe adenomyosis group | – | Other: Treatment protocoldisease extent: > 50% of uterine volume affected by adenomyosis |
| Control group | – | Other: Treatment protocolReceiving IVF treatment because of common factor, such as fallopian tube factors |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This trial aims to evaluate the impact of uterine adenomyosis on the pregnancy outcomes of patients undergoing IVF for assisted conception. The study population consists of individuals aged 20-38 years, diagnosed with uterine adenomyosis or general assisted conception patients, diagnosed by ultrasound to meet the MUSA criteria, with a BMI of less than 30 kg/m2, an AMH level of ≥ 0.8 ng/ml, excluding those with uterine fibroids, untreated intrauterine space-occupying lesions, and diseases such as RSA and RIF, and who have not received ICSI and PGT treatments.
Key inclusion criteria (5 listed)
- Age of all participants ≥ 20 and< 38 years.
- Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors.
- Conforming to MUSA criteria.
- Body mass index < 30 kg/m2.
- The level of AMH ≥ 0.8 ng/ml.
Key exclusion criteria (5 listed)
- Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids < 3 cm).
- Untreated endometrial polyps, hydrosalpinges or uterine adhesions.
- RSA or RIF.
- Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
- Concurrent and/or recent involvement in other research within previous 3 months of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment protocolTreatment 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. | Other | Control group, Mild adenomyosis group, Moderate adenomyosis group, Severe adenomyosis group |
Primary outcome
cumulative live birth rate
Time frame: 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.
5 secondary outcomes
implantation rate
Time frame: from transplantation to delivery
biochemical pregnancy rate
Time frame: from transplantation to pregnancy
ectopic pregnancy rate
Time frame: from transplantation to clinical pregnancy
miscarriage rate
Time frame: pregnancy loss before 28 gestational weeks
clinical pregnancy rate
Time frame: pregnancy loss before 28 gestational weeks
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 21 Aug 2025.
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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.
Lin l Cui, M.D., Ph.D. study chair
The Second Hospital of Shandong University, China
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 Adenomyosis and in Vitro Fertilization, 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 5 inclusion and 5 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 21 Aug 2025. 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 pregnancy to delivery). 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 21 Aug 2025.