Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1
Guangzhou, Guangdong, 510000, China
NCT Number: NCT07065539
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.
Trial opening soon.
Get Notified20 year–38 year
Female
Interventional
Not applicable
Guangzhou, Guangdong, 510000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 40 weeks after embryo transfer
Time frame: 3 weeks after initiating artificial cycle
Time frame: 4 weeks after 3.75mg GnRH-a intramuscular injection
Time frame: 2 weeks post embryo transfer
Time frame: 3 weeks post embryo transfer
Time frame: 5 weeks post embryo transfer
Time frame: 7 weeks' gestation
Time frame: 10 weeks post embryo transfer
Time frame: Prior to 28 weeks' gestation
Time frame: Treatment initiation until 10 weeks' gestation
Time frame: 22, 28, 32, 37 weeks' gestation
Time frame: 24-28 weeks' gestation
Time frame: 20 weeks' gestation to delivery
Time frame: Delivery
Time frame: Delivery
Time frame: Delivery
Time frame: Delivery
Time frame: 6-8 weeks' gestation
Time frame: 28 weeks' gestation to delivery
Time frame: First 28 days postnatal
Time frame: Enrollment until 6 months postpartum
Contact information is provided by the study sponsor or research team.
Yanwen Xu
CONTACT
Yujing Xiong
CONTACT
First Affiliated Hospital, Sun Yat-Sen University
Other
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
Acronym: GOLD-FET
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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