GnRH Agonist Pretreatment Duration and Letrozole Supplementation in Frozen Embryo Transfer for Adenomyosis Patients

NCT07065539 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Phase

Not applicable

Started

2025-07-20

Last updated

2025-07-15

Condition(s) studied

Adenomyosis of UterusFrozen Embryo Transfer (FET)

Investigational drug(s) / intervention(s)

GnRH-a-1MGnRH-a-2MGnRH-a+LE-1MGnRH-a+LE-2M

GnRH-a-1M: Pre-treatment with one dose GnRH agonist before endometrial preparation.

GnRH-a-2M: Pre-treatment with two doses GnRH agonist before endometrial preparation.

GnRH-a+LE-1M: Pre-treatment with one dose GnRH agonist, along with daily 2.5 mg letrozole for 28 days before endometrial preparation.

GnRH-a+LE-2M: Pre-treatment with two doses GnRH agonist, along with daily 2.5 mg letrozole for 28 days since the first injection of GnRH agonist before endometrial preparation.

Study summary

This randomized clinical trial aims to assess the comparative effectiveness of different pre-treatment protocols prior to frozen embryo transfer (FET) among women with adenomyosis, providing evidence-based guidance for clinical decision-making. The main questions it aims to answer are:

Does the protocol involving two doses of gonadotropin-releasing hormone agonist (GnRH-a) pretreatment result in a higher live birth rate compared to one dose of GnRH-a pretreatment in women with adenomyosis undergoing frozen embryo transfer? Does the protocol involving GnRH-a with letrozole supplementation result in a higher live birth rate compared to GnRH-a monotherapy in women with adenomyosis undergoing frozen embryo transfer? Eligible participants will undergo screening before endometrial preparation for FET, following which they will be randomly assigned to one of four groups: GnRH-a-1M, GnRH-a-2M, GnRH-a+LE-1M or GnRH-a+LE-2M. In the GnRH-a-1M group, participants will be pre-treated with one dose GnRH agonist before endometrial preparation. In the GnRH-a-2M group, participants will be pre-treated with two doses GnRH agonist before endometrial preparation. In the GnRH-a+LE-1M group, participants will be pre-treated with one dose GnRH agonist and letrozole 28 days before endometrial preparation. In the GnRH-a+LE-2M group, participants will be pre-treated with two doses GnRH agonist, along with daily 2.5 mg letrozole for 28 days since the first injection of GnRH agonist before endometrial preparation. After pre-treament, all participants will return for endometrial preparation in artificial cycles.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

38 Years

Healthy volunteers

Inclusion Criteria: * Sonographically diagnosed adenomyosis via transvaginal ultrasound; * Candidates scheduled for frozen single blastocyst (Day5, Day6) transfer * Age 20-38 years * Previous embryo transfer attempts: ≤2 cycles Exclusion Criteria: * Patients diagnosed with Recurrent pregnancy loss, Autoimmune disorders (e.g., systemic lupus erythematosus), Uterine fibroids ≥5 cm, Cervical incompetence, Cesarean scar niche * History of Myomectomy and/or adenomyosis lesion excision, Cervical conization * Patients presenting with Congenital Müllerian anomalies (unicornuate uterus, septate uterus, etc.), Endometrial atypical hyperplasia, malignancy or defects * Sperm retrieval method: Micro-TESE (microdissection testicular sperm extraction) * Fertilization method: Rescue ICSI * Endometrial thickness \<7 mm, Intrauterine adhesions, Intrauterine fluid * Contraindications to exogenous hormone administration * Use of GnRH within 3 months prior to enrollment

Primary outcome measure(s)

Live birth rate — 40 weeks after embryo transfer

Trial sites (1)

Facility	City	Region	Status
Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07065539 on ClinicalTrials.gov ↗ ← All trials in China