Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07065539

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510000, China

Location contact

Yujing Xiong, Doctor

CONTACT

[email protected]

+8618816899615

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRH-a-1M

Drug

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

GnRH-a-2M

Drug

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

GnRH-a+LE-1M

Drug

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

GnRH-a+LE-2M

Drug

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 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yanwen Xu

CONTACT

[email protected]

+8613682213000

Yujing Xiong

CONTACT

[email protected]

+8618816899615

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • BoAi Hospital of Zhongshan
  • Fujian Maternity and Child Health Hospital

Registry information

Official study 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

Acronym: GOLD-FET

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.