GnRH Agonist Pretreatment Duration and Letrozole Supplementation in Frozen Embryo Transfer for Adenomyosis Patients

Not Applicable

Not yet recruiting

• Conditions: Adenomyosis of Uterus; Frozen Embryo Transfer (FET)
• Interventions: Drug: GnRH-a-1M; Drug: GnRH-a-2M; Drug: GnRH-a+LE-1M; Drug: GnRH-a+LE-2M

• Registration Number: NCT07065539
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-13
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-07-20
• Primary Completion: 2027-05
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 432

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
GnRH-a-1M	GnRH-a-1M	-
GnRH-a-2M	GnRH-a-2M	-
GnRH-a+LE-1M	GnRH-a+LE-1M	-
GnRH-a+LE-2M	GnRH-a+LE-2M	-

Primary Outcome Measures

Name	Time	Method
Live birth rate	40 weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
Cycle Cancellation Rate	3 weeks after initiating artificial cycle
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
Gestational Diabetes Mellitus (GDM) Incidence	24-28 weeks' gestation
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

Trial Locations

Locations (1)

Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1; 🇨🇳 Guangzhou, Guangdong, China