GnRH Agonist Pretreatment in Persistent Chronic Endometritis Undergoing FET

NCT07642700 | Not Yet Recruiting

• 1 other identifier: PCE
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

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

  6-7 weeks

Secondary Outcomes (2)

• miscarriage rate

  24 weeks

• Live birth rate

  37 weeks

Study Arms (2)

GnRH/HRT

PCE patients with GnRH agonist pretreatment combined with hormone replacement therapy (GnRH-HRT) endometrial preparation

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),

Drug: Conventional estrogen-progesterone artificial cycle for endometrial preparation

Interventions

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.

non-GnRH-HRT

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.

GnRH/HRT

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guoxia Yang: lead

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician, Reproductive Medicine Department

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06