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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
432
Pre-treatment with one dose GnRH agonist before endometrial preparation.
Pre-treatment with two doses GnRH agonist before endometrial preparation.
Pre-treatment with one dose GnRH agonist, along with daily 2.5 mg letrozole for 28 days before endometrial preparation.
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.
Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1
Guangzhou, Guangdong, China
Live birth rate
Time frame: 40 weeks after embryo transfer
Cycle Cancellation Rate
Time frame: 3 weeks after initiating artificial cycle
Hypoestrogenic Adverse Event Rate
Time frame: 4 weeks after 3.75mg GnRH-a intramuscular injection
Positive Pregnancy Test Rate
Time frame: 2 weeks post embryo transfer
Embryo Implantation Rate
Time frame: 3 weeks post embryo transfer
Clinical Pregnancy Rate
Time frame: 5 weeks post embryo transfer
Ectopic Pregnancy Rate
Time frame: 7 weeks' gestation
Ongoing Pregnancy Rate
Time frame: 10 weeks post embryo transfer
Miscarriage Rate
Time frame: Prior to 28 weeks' gestation
Drug-Related Venous Thromboembolism (VTE) Rate
Time frame: Treatment initiation until 10 weeks' gestation
Preterm Birth Rate
Time frame: 22, 28, 32, 37 weeks' gestation
Gestational Diabetes Mellitus (GDM) Incidence
Time frame: 24-28 weeks' gestation
Rate of Hypertension in Pregnancy
Time frame: 20 weeks' gestation to delivery
Low Birth Weight Rate
Time frame: Delivery
Very Low Birth Weight Rate
Time frame: Delivery
Macrosomia Rate
Time frame: Delivery
Extreme Macrosomia Rate
Time frame: Delivery
Multiple Pregnancy Rate
Time frame: 6-8 weeks' gestation
Stillbirth Rate
Time frame: 28 weeks' gestation to delivery
Neonatal Mortality Rate
Time frame: First 28 days postnatal
Adverse Event Incidence
Time frame: Enrollment until 6 months postpartum
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