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GnRH Agonist Pretreatment Duration and Letrozole Supplementation in Frozen Embryo Transfer for Adenomyosis Patients
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
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.
Official title: The Impact of Duration of Gonadotropin-Releasing Hormone Agonist Pretreatment and Letrozole Supplementation on Pregnancy Outcomes in Frozen-Thawed Embryo Transfer Cycles for Patients With Adenomyosis: A 2 by 2 Factorial Multicenter, Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
20 Years - 38 Years
Study Type
INTERVENTIONAL
Enrollment
432
Start Date
2025-07-20
Completion Date
2027-12
Last Updated
2025-07-15
Healthy Volunteers
No
Interventions
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.
Locations (1)
Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1
Guangzhou, Guangdong, China