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Adenomyosis of UterusGOLD-FETNCT07065539

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

A study testing GnRH-a-1M, GnRH-a-2M and GnRH-a+LE-1M in people with Adenomyosis of Uterus and Frozen Embryo Transfer (FET), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 38 years, women only
What is being tested?
GnRH-a-1M, GnRH-a-2M and GnRH-a+LE-1M
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
1 siteChina
Study dates
20 Jul 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanwen Xu contact

+8613682213000

xuyanwen@mail.sysu.edu.cn

Yujing Xiong contact

+8618816899615

xiongyj3@mail.sysu.edu.cn

China1 site

  • Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1

    Guangzhou, Guangdong, 510000

    Yujing Xiong, Doctor, +8618816899615, xiongyujing08@163.com

Other trials in China

About this study

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

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.

Being tested
GnRH-a-1M, GnRH-a-2M, GnRH-a+LE-1M, GnRH-a+LE-2M
Keywords
adenomyosis, embryo transfer, GnRH-a, letrozole, pre-treament
Medical subject headings
Adenomyosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GnRH-a-1MDrug

    Pre-treatment with one dose GnRH agonist before endometrial preparation.

  • GnRH-a-2MDrug

    Pre-treatment with two doses GnRH agonist before endometrial preparation.

  • GnRH-a+LE-1MDrug

    Pre-treatment with one dose GnRH agonist, along with daily 2.5 mg letrozole for 28 days before endometrial preparation.

  • GnRH-a+LE-2MDrug

    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.

Study groups in NCT07065539
Study groupRoleWhat they receive
GnRH-a-1MActive comparatorNot described
Receives: Drug: GnRH-a-1M
GnRH-a-2MActive comparatorNot described
Receives: Drug: GnRH-a-2M
GnRH-a+LE-1MActive comparatorNot described
Receives: Drug: GnRH-a+LE-1M
GnRH-a+LE-2MActive comparatorNot described
Receives: Drug: GnRH-a+LE-2M

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth rate

    Measured: 40 weeks after embryo transfer

Secondary outcomes (20)

  1. Cycle Cancellation Rate

    Measured: 3 weeks after initiating artificial cycle

  2. Hypoestrogenic Adverse Event Rate

    Measured: 4 weeks after 3.75mg GnRH-a intramuscular injection

  3. Positive Pregnancy Test Rate

    Measured: 2 weeks post embryo transfer

  4. Embryo Implantation Rate

    Measured: 3 weeks post embryo transfer

  5. Clinical Pregnancy Rate

    Measured: 5 weeks post embryo transfer

  6. Ectopic Pregnancy Rate

    Measured: 7 weeks' gestation

  7. Ongoing Pregnancy Rate

    Measured: 10 weeks post embryo transfer

  8. Miscarriage Rate

    Measured: Prior to 28 weeks' gestation

  9. Drug-Related Venous Thromboembolism (VTE) Rate

    Measured: Treatment initiation until 10 weeks' gestation

  10. Preterm Birth Rate

    Measured: 22, 28, 32, 37 weeks' gestation

  11. Gestational Diabetes Mellitus (GDM) Incidence

    Measured: 24-28 weeks' gestation

  12. Rate of Hypertension in Pregnancy

    Measured: 20 weeks' gestation to delivery

  13. Low Birth Weight Rate

    Measured: Delivery

  14. Very Low Birth Weight Rate

    Measured: Delivery

  15. Macrosomia Rate

    Measured: Delivery

  16. Extreme Macrosomia Rate

    Measured: Delivery

  17. Multiple Pregnancy Rate

    Measured: 6-8 weeks' gestation

  18. Stillbirth Rate

    Measured: 28 weeks' gestation to delivery

  19. Neonatal Mortality Rate

    Measured: First 28 days postnatal

  20. Adverse Event Incidence

    Measured: Enrollment until 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start20 Jul 2025 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
432 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07065539
Sponsor's protocol ID
2025012-5010
Acronym
GOLD-FET
Status last verified
Jul 2025
First submitted
13 Jun 2025
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: only IPD used in the results publication

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

Questions about this trial

What is this clinical trial studying?

A study testing GnRH-a-1M, GnRH-a-2M and GnRH-a+LE-1M in people with Adenomyosis of Uterus and Frozen Embryo Transfer (FET), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanwen Xu (+8613682213000, xuyanwen@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth rate (time frame: 40 weeks after embryo transfer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07065539, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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