About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Factorial
Treatments tested in this trial
GnRH-a-1M
DrugPre-treatment with one dose GnRH agonist before endometrial preparation.
GnRH-a-2M
DrugPre-treatment with two doses GnRH agonist before endometrial preparation.
GnRH-a+LE-1M
DrugPre-treatment with one dose GnRH agonist, along with daily 2.5 mg letrozole for 28 days before endometrial preparation.
GnRH-a+LE-2M
DrugPre-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.
Treatment groups
Trial outcomes
Primary outcomes
Live birth rate
Secondary outcomes
Cycle Cancellation Rate
Hypoestrogenic Adverse Event Rate
Positive Pregnancy Test Rate
Embryo Implantation Rate
Sponsors and contacts
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First Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Fujian Maternity and Child Health Hospital
Collaborator
BoAi Hospital of Zhongshan
Collaborator
This trial is not recruiting at the moment. You can still explore other options: