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NCT Number: NCT07642700

GnRH Agonist Pretreatment in Persistent Chronic Endometritis Undergoing FET

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,

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. miscarriage rate

    Time frame: 24 weeks

    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.

  2. Live birth rate

    Time frame: 37 weeks

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

Sponsors and collaborators

Lead sponsor

Guoxia Yang

Other

Registry information

Official study title

Association of GnRH Agonist Pretreatment With Pregnancy Outcomes in Women With Persistent Chronic Endometritis Undergoing Frozen Embryo Transfer

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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