AdenomyosisNCT06123975
Adenomyosis Patients With Infertility and Immunological Factors
An observational study of Adenomyosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
Infertile patients with adenomyosis who met the inclusion and exclusion criteria, after signing the informed consent form, the researchers recorded the clinical information of the patients and initiated the in vitro fertilization-embryo transfer (IVF-ET) procedure. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Venous blood collection
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile patients with adenomyosis who underwent IVF-ET at the Reproductive Center of the Peking University Third Hospital
Who may be able to join
- Patients were diagnosed as adenomyosis by transvaginal ultrasound scans (The criteria for sonographic diagnosis of adenomyosis are with 2 or more of the following: heterogeneous myometrial texture with the presence of globular asymmetric uterus, thickening of the anterior and posterior myometrial wall, irregular cystic areas within the myometrium);
- 18≤ age ≤ 40 years old at first outpatient visit in our Reproductive Center;
- with regular menstrual cycle.
Who cannot join
- Patients with intrauterine adhesion, uterine malformation, submucosal leiomyoma, or ≥ 5.0 cm in diameter leiomyoma;
- hydrosalpinx and systemic diseases;
- patients with other endocrine severe diseases, immune diseases, tumors and abnormal chromosomes in either partner.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Wen Zhang
About this study
Official title: Study of the Role of Immunologic Factors in Adenomyosis Patients With Infertility
Infertile patients with adenomyosis who met the inclusion and exclusion criteria, after signing the informed consent form, the researchers recorded the clinical information of the patients and initiated the in vitro fertilization-embryo transfer (IVF-ET) procedure. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. By analyzing the changes of immune cells and molecules in the peripheral blood of the patients, role of immune factors in infertility combined with adenomyosis was further explored.
Read the detailed description
Adenomyosis is a common gynecological disease in women of reproductive age which is characterized by endometrial glands and stroma in the normal myometrium, accompanied by hypertrophy of the surrounding myometrial smooth muscle cells.The results of several studies showed that clinical pregnancy rate and live birth rate of in vitro fertilization-embryo transfer decreased in infertile patients with adenomyosis. This study intends to explore the immune-related mechanisms in infertile patients with uterine adenomyosis, with a view to finding effective clinical intervention targets for adenomyosis associated infertility, and providing new clues for the prevention and treatment of adenomyosis associated infertility. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. The basic characteristics of the participants, such as age, body mass index, infertility type, infertility duration, gravida, parity times, basal follicle-stimulating hormone (FSH), anti-Müllerian hormone, uterine volume before IVF cycle, controlled ovulation hyperstimulation (COH) protocol, endometrial thickness, number of embryos transferred, transferred embryo type (cleavage embryo/blastocyst) were evaluated. Pregnancy outcomes of all patients were followed up. By analyzing the changes of immune cells and molecules in the peripheral blood of the patients, role of immune factors in infertility combined with adenomyosis was further explored.
- Conditions
- Adenomyosis
- Being tested
- Venous blood collection
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood collectionOther
Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Adenomyosis Cohort | Infertile patients with adenomyosis who met the inclusion and exclusion criteria, after signing the informed consent form, the researchers recorded the clinical information of the patients and initiated the IVF-ET procedure. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. Receives: Other: Venous blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy denoted evidence of at least one intrauterine gestational sac observed by ultrasonography 30 days after embryo transfer. Clinical pregnancy rate = Number of patients who achieved clinical pregnancy / Number of transplant cycles.
Measured: Within 10 weeks after embryo transfer
Miscarriage rate
Miscarriage was defined as the presence of an intrauterine gestational sac but no subsequent live birth after 24 weeks of gestation. Miscarriage rate = Number of patients with miscarriage / Number of patients who achieved clinical pregnancy.
Measured: Within 24 weeks after embryo transfer
Live birth rate
Live birth was defined as delivery of a live baby after 24 weeks of gestation. Live birth rate = Number of patients with live birth / Number of transplant cycles.
Measured: Within 1 year after embryo transfer
Secondary outcomes (1)
Immune cells and molecules in the peripheral blood
Immune cells and molecules in the peripheral blood on the day of embryo transfer, 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation.
Measured: Within 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Mar 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Zhang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123975
- Sponsor's protocol ID
- LM2021242
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Immunologic Factors in Adenomyosis Patients With Infertility
- ClinicalTrials.gov ID
- NCT06123975
- Acronym / sponsor ID
- LM2021242
- Conditions
- Adenomyosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Nov 2023 (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.
Infertile patients with adenomyosis who met the inclusion and exclusion criteria, after signing the informed consent form, the researchers recorded the clinical information of the patients and initiated the in vitro fertilization-embryo transfer (IVF-ET) procedure. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. By analyzing the changes of immune cells and molecules in the peripheral blood of the patients, role of immune factors in infertility combined with adenomyosis was further explored.
Detailed description
Adenomyosis is a common gynecological disease in women of reproductive age which is characterized by endometrial glands and stroma in the normal myometrium, accompanied by hypertrophy of the surrounding myometrial smooth muscle cells.The results of several studies showed that clinical pregnancy rate and live birth rate of in vitro fertilization-embryo transfer decreased in infertile patients with adenomyosis. This study intends to explore the immune-related mechanisms in infertile patients with uterine adenomyosis, with a view to finding effective clinical intervention targets for adenomyosis associated infertility, and providing new clues for the prevention and treatment of adenomyosis associated infertility. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. The basic characteristics of the participants, such as age, body mass index, infertility type, infertility duration, gravida, parity times, basal follicle-stimulating hormone (FSH), anti-Müllerian hormone, uterine volume before IVF cycle, controlled ovulation hyperstimulation (COH) protocol, endometrial thickness, number of embryos transferred, transferred embryo type (cleavage embryo/blastocyst) were evaluated. Pregnancy outcomes of all patients were followed up. By analyzing the changes of immune cells and molecules in the peripheral blood of the patients, role of immune factors in infertility combined with adenomyosis was further explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenomyosis Cohort | – | Other: Venous blood collectionInfertile patients with adenomyosis who met the inclusion and exclusion criteria, after signing the informed consent form, the researchers recorded the clinical information of the patients and initiated the IVF-ET procedure. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile patients with adenomyosis who underwent IVF-ET at the Reproductive Center of the Peking University Third Hospital
Key inclusion criteria (3 listed)
- Patients were diagnosed as adenomyosis by transvaginal ultrasound scans (The criteria for sonographic diagnosis of adenomyosis are with 2 or more of the following: heterogeneous myometrial texture with the presence of globular asymmetric uterus, thickening of the anterior and posterior myometrial wall, irregular cystic areas within the myometrium);
- 18≤ age ≤ 40 years old at first outpatient visit in our Reproductive Center;
- with regular menstrual cycle.
Key exclusion criteria (3 listed)
- Patients with intrauterine adhesion, uterine malformation, submucosal leiomyoma, or ≥ 5.0 cm in diameter leiomyoma;
- hydrosalpinx and systemic diseases;
- patients with other endocrine severe diseases, immune diseases, tumors and abnormal chromosomes in either partner.
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 |
|---|---|---|
| Venous blood collectionPeripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. | Other | Adenomyosis Cohort |
Primary outcome
Clinical pregnancy rate
Time frame: Within 10 weeks after embryo transfer
Clinical pregnancy denoted evidence of at least one intrauterine gestational sac observed by ultrasonography 30 days after embryo transfer. Clinical pregnancy rate = Number of patients who achieved clinical pregnancy / Number of transplant cycles.
Miscarriage rate
Time frame: Within 24 weeks after embryo transfer
Miscarriage was defined as the presence of an intrauterine gestational sac but no subsequent live birth after 24 weeks of gestation. Miscarriage rate = Number of patients with miscarriage / Number of patients who achieved clinical pregnancy.
Live birth rate
Time frame: Within 1 year after embryo transfer
Live birth was defined as delivery of a live baby after 24 weeks of gestation. Live birth rate = Number of patients with live birth / Number of transplant cycles.
1 secondary outcome
Immune cells and molecules in the peripheral blood
Time frame: Within 12 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Wen Zhang principal investigator
Peking University Third Hospital
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, run by Peking University Third Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Zhang (15510659339, chaodongxiehe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: Within 10 weeks after embryo transfer). The study lists 3 primary outcomes in all. 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 15 Apr 2024.