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Not yet recruitingNCT07065539GOLD-FETUpdated Jul 15, 2025

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

An interventional study of GnRH-a-1M and GnRH-a-2M in Adenomyosis of Uterus and Frozen Embryo Transfer (FET), sponsored by First Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
432
Allocation
Randomized
Ages
20 Years to 38 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Adenomyosis of Uterus
  • Frozen Embryo Transfer (FET)

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Keywords

  • adenomyosis
  • embryo transfer
  • GnRH-a
  • letrozole
  • pre-treament
03

In context

Adenomyosis

135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.

This study's planned enrollment of 432 is above the median of 100 across 73 interventional studies indexed under Adenomyosis.

Browse Adenomyosis studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 38 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
432 participants (estimated)

Study arms

  • Active comparator
    GnRH-a-1M

    Drug: GnRH-a-1M

  • Active comparator
    GnRH-a-2M

    Drug: GnRH-a-2M

  • Active comparator
    GnRH-a+LE-1M

    Drug: GnRH-a+LE-1M

  • Active comparator
    GnRH-a+LE-2M

    Drug: GnRH-a+LE-2M

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.

06

What researchers measure

Primary outcomes

  1. Live birth rate

    Time frame: 40 weeks after embryo transfer

Secondary outcomes

  1. Cycle Cancellation Rate

    Time frame: 3 weeks after initiating artificial cycle

  2. Hypoestrogenic Adverse Event Rate

    Time frame: 4 weeks after 3.75mg GnRH-a intramuscular injection

  3. Positive Pregnancy Test Rate

    Time frame: 2 weeks post embryo transfer

  4. Embryo Implantation Rate

    Time frame: 3 weeks post embryo transfer

  5. Clinical Pregnancy Rate

    Time frame: 5 weeks post embryo transfer

  6. Ectopic Pregnancy Rate

    Time frame: 7 weeks' gestation

  7. Ongoing Pregnancy Rate

    Time frame: 10 weeks post embryo transfer

  8. Miscarriage Rate

    Time frame: Prior to 28 weeks' gestation

  9. Drug-Related Venous Thromboembolism (VTE) Rate

    Time frame: Treatment initiation until 10 weeks' gestation

  10. Preterm Birth Rate

    Time frame: 22, 28, 32, 37 weeks' gestation

  11. Gestational Diabetes Mellitus (GDM) Incidence

    Time frame: 24-28 weeks' gestation

  12. Rate of Hypertension in Pregnancy

    Time frame: 20 weeks' gestation to delivery

  13. Low Birth Weight Rate

    Time frame: Delivery

  14. Very Low Birth Weight Rate

    Time frame: Delivery

  15. Macrosomia Rate

    Time frame: Delivery

  16. Extreme Macrosomia Rate

    Time frame: Delivery

  17. Multiple Pregnancy Rate

    Time frame: 6-8 weeks' gestation

  18. Stillbirth Rate

    Time frame: 28 weeks' gestation to delivery

  19. Neonatal Mortality Rate

    Time frame: First 28 days postnatal

  20. Adverse Event Incidence

    Time frame: Enrollment until 6 months postpartum

07

Study locations

1 site
  • Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1
    Guangzhou, Guangdong 510000, China
08

References and documents

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. PubMed 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. PubMed 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. 2022 Jul;60(1):118-131. doi: 10.1002/uog.24786. PubMed 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. PubMed 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. PubMed 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. doi: 10.1186/s13063-026-09731-2. PubMed 42032741 ↗

Individual participant data

Plan to share: Yes — only IPD used in the results publication

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07065539
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborators
Fujian Maternity and Child Health Hospital, BoAi Hospital of Zhongshan
Responsible party
Yanwen Xu (Director of the Reproductive Medical Center, the First Affliated Hospital of Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Jul 15, 2025
Start date
Jul 20, 2025 (estimated)
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 15, 2025

Study contacts

Yanwen Xu
Contact
xuyanwen@mail.sysu.edu.cn
+8613682213000
Yujing Xiong
Contact
xiongyj3@mail.sysu.edu.cn
+8618816899615
Yanwen Xu
principal investigator · Center for Reproductive Medicine, The First Affiliated Hospital of Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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