Adenomyosis of Uterus, Frozen Embryo Transfer (FET)
Conditions
Keywords
adenomyosis, embryo transfer, GnRH-a, letrozole, pre-treament
Brief 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.
Interventions
DRUGGnRH-a-1M
Pre-treatment with one dose GnRH agonist before endometrial preparation.
DRUGGnRH-a-2M
Pre-treatment with two doses GnRH agonist before endometrial preparation.
DRUGGnRH-a+LE-1M
Pre-treatment with one dose GnRH agonist, along with daily 2.5 mg letrozole for 28 days before endometrial preparation.
DRUGGnRH-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.
Sponsors
Women and Children's Hospital of Fujian Province
BoAi Hospital of Zhongshan
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate | 40 weeks after embryo transfer |
Secondary
| Measure | Time frame |
|---|---|
| Hypoestrogenic Adverse Event Rate | 4 weeks after 3.75mg GnRH-a intramuscular injection |
| Positive Pregnancy Test Rate | 2 weeks post embryo transfer |
| Embryo Implantation Rate | 3 weeks post embryo transfer |
| Clinical Pregnancy Rate | 5 weeks post embryo transfer |
| Ectopic Pregnancy Rate | 7 weeks' gestation |
| Ongoing Pregnancy Rate | 10 weeks post embryo transfer |
| Miscarriage Rate | Prior to 28 weeks' gestation |
| Drug-Related Venous Thromboembolism (VTE) Rate | Treatment initiation until 10 weeks' gestation |
| Preterm Birth Rate | 22, 28, 32, 37 weeks' gestation |
| Cycle Cancellation Rate | 3 weeks after initiating artificial cycle |
| Rate of Hypertension in Pregnancy | 20 weeks' gestation to delivery |
| Low Birth Weight Rate | Delivery |
| Very Low Birth Weight Rate | Delivery |
| Macrosomia Rate | Delivery |
| Extreme Macrosomia Rate | Delivery |
| Multiple Pregnancy Rate | 6-8 weeks' gestation |
| Stillbirth Rate | 28 weeks' gestation to delivery |
| Neonatal Mortality Rate | First 28 days postnatal |
| Adverse Event Incidence | Enrollment until 6 months postpartum |
| Gestational Diabetes Mellitus (GDM) Incidence | 24-28 weeks' gestation |
Countries
China
Contacts
Primary ContactYanwen Xu
Backup ContactYujing Xiong
Outcome results
None listed