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GnRH Agonist Pretreatment in Persistent Chronic Endometritis Undergoing FET

ConditionChronic Endometritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-40
SponsorGuoxia Yang

About this trial

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,

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Conventional estrogen-progesterone artificial cycle for endometrial preparation

    Drug

    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 preparation

    Drug

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: GnRH/HRT1 intervention
Group B: non-GnRH-HRT1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6-7 weeks

Secondary outcomes

1

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.

Time frame
24 weeks
2

Live birth rate

Live birth was defined as the delivery of at least one live-born infant at ≥24 weeks of gestation.

Time frame
37 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guoxia Yang

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: