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Not yet recruiting NCT07065539

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

No phase Interventional Adenomyosis of Uterus Frozen Embryo Transfer (FET)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GnRH-a-1M, GnRH-a-2M, GnRH-a+LE-1M, GnRH-a+LE-2M.
Who it may be relevant to
Registry conditions: Adenomyosis of Uterus, Frozen Embryo Transfer (FET). Basic parameters: 20 years — 38 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug GnRH-a-1M
    Pre-treatment with one dose GnRH agonist before endometrial preparation.
  • Drug GnRH-a-2M
    Pre-treatment with two doses GnRH agonist before endometrial preparation.
  • Drug GnRH-a+LE-1M
    Pre-treatment with one dose GnRH agonist, along with daily 2.5 mg letrozole for 28 days before endometrial preparation.
  • Drug GnRH-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.

Primary outcome measures

  • Live birth rate [Time frame: 40 weeks after embryo transfer]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhong — Guangzhou

Publications

  • Badawy AM, Elnashar AM, Mosbah AA. Aromatase inhibitors or gonadotropin-releasing hormone agonists for the management of uterine adenomyosis: a randomized controlled trial. Acta Obstet Gynecol Scand. 2012 Apr;91(4):489-95. doi: 10.1111/j.1600-0412.2012.01350.x. PMID 22229256
  • Duhan N, Madaan S, Sen J. Role of the aromatase inhibitor letrozole in the management of uterine leiomyomas in premenopausal women. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):329-32. doi: 10.1016/j.ejogrb.2013.09.010. Epub 2013 Sep 20. PMID 24103533
  • Harmsen MJ, Van den Bosch T, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Hehenkamp WJK, Groenman F, De Bruyn C, Rasmussen C, Lazzeri L, Jokubkiene L, Jurkovic D, Naftalin J, Tellum T, Bourne T, Timmerman D, Huirne JAF. Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure. Ultrasound Obstet Gynecol PMID 34587658
  • Selntigia A, Molinaro P, Tartaglia S, Pellicer A, Galliano D, Cozzolino M. Adenomyosis: An Update Concerning Diagnosis, Treatment, and Fertility. J Clin Med. 2024 Sep 3;13(17):5224. doi: 10.3390/jcm13175224. PMID 39274438
  • Struble J, Reid S, Bedaiwy MA. Adenomyosis: A Clinical Review of a Challenging Gynecologic Condition. J Minim Invasive Gynecol. 2016 Feb 1;23(2):164-85. doi: 10.1016/j.jmig.2015.09.018. Epub 2015 Sep 30. PMID 26427702
  • Xiong Y, Gu F, Du L, Gu J, Ke Z, Xu Y, Mol BW, Zheng B, Lin X, Xu Y. Gonadotropin-releasing hormone agonist (GnRH-a) pretreatment duration and letrozole supplementation for optimizing live birth rates in women with adenomyosis undergoing frozen-thawed embryo transfer (GOLD-FET): study protocol for a multicenter, 2 x 2 factorial randomized controlled trial in China. Trials. 2026 Apr 24;27(1):421. d PMID 42032741

Identifiers

NCT: NCT07065539 · 2025012-5010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗