Chronic EndometritisNCT07642700
GnRH Agonist Pretreatment in Persistent Chronic Endometritis Undergoing FET
An observational study of Chronic Endometritis, run by Guoxia Yang.
Trial summary
Women with PCE represent a treatment-resistant phenotype in whom the endometrial inflammatory and immune status remains abnormal despite antibiotic therapy. GnRH agonist pretreatment may be most beneficial in endometrial phenotypes marked by persistent or residual inflammatory impairment rather than in all frozen… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chronic Endometritis
- What is being tested?
- Conventional estrogen-progesterone artificial cycle for endometrial preparation and GnRH agonist plus estrogen-progesterone for endometrial preparation
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2028
- 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 40 years
- Women only
- Adult
Study population: This prospective cohort study enrolls infertile patients diagnosed with persistent chronic endometritis who receive FET in reproductive center. Subjects are allocated into two groups: down-regulation endometrial preparation group and conventional artificial cycle or natural cycle group. We compare implantation, clinical pregnancy, miscarriage and live birth rates between two regimens.
Who may be able to join
- Aged 20-40 years; confirmed persistent chronic endometritis (PCE) via hysteroscopy plus CD138 immunohistochemistry, defined as positive endometrial pathology after two-course antibiotic treatment for CE.
- Frozen-thawed embryo transfer (FET) with available transferable cleavage-stage or blastocyst embryos from IVF/ICSI cycles.
- No acute pelvic infection at enrollment; ≥1 month elapsed after completion of last antibiotic therapy for endometritis.
- Normal uterine cavity except for inflammatory changes of PCE; no severe uterine malformation or severe intrauterine adhesion requiring surgical intervention.
- Voluntarily sign informed consent and complete full follow-up of pregnancy outcomes
Who cannot join
- History of pelvic tuberculosis, intrauterine adhesions, submucous uterine myoma or endometrial polyp before FET
- Uncontrolled systemic endocrine disorders, autoimmune diseases (APS, SLE), severe hepatic/renal/cardiopulmonary dysfunction.
- Known allergy to GnRH agonist for down-regulation regimen; prior long-acting GnRH-a intolerance.
- Recent use of immunosuppressant, long-term glucocorticoid or drugs interfering endometrial development within 3 months before enrollment.
- Lost to follow-up or plan to abandon embryo transfer after enrollment.
About this study
Official title: Association of GnRH Agonist Pretreatment With Pregnancy Outcomes in Women With Persistent Chronic Endometritis Undergoing Frozen Embryo Transfer
Women with PCE represent a treatment-resistant phenotype in whom the endometrial inflammatory and immune status remains abnormal despite antibiotic therapy. GnRH agonist pretreatment may be most beneficial in endometrial phenotypes marked by persistent or residual inflammatory impairment rather than in all frozen embryo transfer populations.We therefore conducted a single-center prospective cohort study to investigate whether GnRH-HRT, compared with non-GnRH-based preparations, improve clinical pregnancy and live birth in women with PCE undergoing FET,
- Conditions
- Chronic Endometritis
- Being tested
- Conventional estrogen-progesterone artificial cycle for endometrial preparation, GnRH agonist plus estrogen-progesterone for endometrial preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional estrogen-progesterone artificial cycle for endometrial preparationDrug
No GnRH-a down-regulation. Oral estrogen is initiated directly on early menstrual cycle, followed by progesterone transformation to prepare endometrium for FET in patients with persistent chronic endometritis.
GnRH agonist plus estrogen-progesterone for endometrial preparationDrug
Long-acting GnRH agonist is administered on day 2-3 of menstruation for pituitary down-regulation. After satisfactory hormonal suppression, sequential oral estrogen and progesterone are used to prepare endometrium before frozen embryo transfer in patients with persistent chronic endometritis.
| Study group | Role | What they receive |
|---|---|---|
| GnRH/HRT | PCE patients with GnRH agonist pretreatment combined with hormone replacement therapy (GnRH-HRT) endometrial preparation Receives: Drug: GnRH agonist plus estrogen-progesterone for endometrial preparation | |
| non-GnRH-HRT | PCE patients with non-GnRH-HRT regimens (HRT alone or natural cycle, NC), Receives: Drug: Conventional estrogen-progesterone artificial cycle for endometrial preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy was defined as the visualization of at least one gestational sac on transvaginal ultrasonography at 6-7 weeks of gestation
Measured: 6-7 weeks
Secondary outcomes (2)
miscarriage rate
Miscarriage rate was defined as the proportion of clinical pregnancies ending in spontaneous pregnancy loss before 24 gestational weeks. Early miscarriage was defined as pregnancy loss occurring before 12 weeks of gestation.
Measured: 24 weeks
Live birth rate
Live birth was defined as the delivery of at least one live-born infant at ≥24 weeks of gestation.
Measured: 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EndometritisStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guoxia Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guoxia Yang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642700
- Sponsor's protocol ID
- PCE
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of GnRH Agonist Pretreatment With Pregnancy Outcomes in Women With Persistent Chronic Endometritis Undergoing Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT07642700
- Acronym / sponsor ID
- PCE
- Conditions
- Chronic Endometritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guoxia YangUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 11 Jun 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.
Women with PCE represent a treatment-resistant phenotype in whom the endometrial inflammatory and immune status remains abnormal despite antibiotic therapy. GnRH agonist pretreatment may be most beneficial in endometrial phenotypes marked by persistent or residual inflammatory impairment rather than in all frozen embryo transfer populations.We therefore conducted a single-center prospective cohort study to investigate whether GnRH-HRT, compared with non-GnRH-based preparations, improve clinical pregnancy and live birth in women with PCE undergoing FET,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH/HRT | – | Drug: GnRH agonist plus estrogen-progesterone for endometrial preparationPCE patients with GnRH agonist pretreatment combined with hormone replacement therapy (GnRH-HRT) endometrial preparation |
| non-GnRH-HRT | – | Drug: Conventional estrogen-progesterone artificial cycle for endometrial preparationPCE patients with non-GnRH-HRT regimens (HRT alone or natural cycle, NC), |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This prospective cohort study enrolls infertile patients diagnosed with persistent chronic endometritis who receive FET in reproductive center. Subjects are allocated into two groups: down-regulation endometrial preparation group and conventional artificial cycle or natural cycle group. We compare implantation, clinical pregnancy, miscarriage and live birth rates between two regimens.
Key inclusion criteria (5 listed)
- Aged 20-40 years; confirmed persistent chronic endometritis (PCE) via hysteroscopy plus CD138 immunohistochemistry, defined as positive endometrial pathology after two-course antibiotic treatment for CE.
- Frozen-thawed embryo transfer (FET) with available transferable cleavage-stage or blastocyst embryos from IVF/ICSI cycles.
- No acute pelvic infection at enrollment; ≥1 month elapsed after completion of last antibiotic therapy for endometritis.
- Normal uterine cavity except for inflammatory changes of PCE; no severe uterine malformation or severe intrauterine adhesion requiring surgical intervention.
- Voluntarily sign informed consent and complete full follow-up of pregnancy outcomes
Key exclusion criteria (5 listed)
- History of pelvic tuberculosis, intrauterine adhesions, submucous uterine myoma or endometrial polyp before FET
- Uncontrolled systemic endocrine disorders, autoimmune diseases (APS, SLE), severe hepatic/renal/cardiopulmonary dysfunction.
- Known allergy to GnRH agonist for down-regulation regimen; prior long-acting GnRH-a intolerance.
- Recent use of immunosuppressant, long-term glucocorticoid or drugs interfering endometrial development within 3 months before enrollment.
- Lost to follow-up or plan to abandon embryo transfer after enrollment.
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 |
|---|---|---|
| Conventional estrogen-progesterone artificial cycle for endometrial preparationNo GnRH-a down-regulation. Oral estrogen is initiated directly on early menstrual cycle, followed by progesterone transformation to prepare endometrium for FET in patients with persistent chronic endometritis. | Drug | non-GnRH-HRT |
| GnRH agonist plus estrogen-progesterone for endometrial preparationLong-acting GnRH agonist is administered on day 2-3 of menstruation for pituitary down-regulation. After satisfactory hormonal suppression, sequential oral estrogen and progesterone are used to prepare endometrium before frozen embryo transfer in patients with persistent chronic endometritis. | Drug | GnRH/HRT |
Primary outcome
Clinical pregnancy rate
Time frame: 6-7 weeks
Clinical pregnancy was defined as the visualization of at least one gestational sac on transvaginal ultrasonography at 6-7 weeks of gestation
2 secondary outcomes
miscarriage rate
Time frame: 24 weeks
Live birth rate
Time frame: 37 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 11 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Endometritis, run by Guoxia Yang.
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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical pregnancy rate (time frame: 6-7 weeks). 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 11 Jun 2026.