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| Name | Class |
|---|---|
| Fujian Maternity and Child Health Hospital | OTHER |
| BoAi Hospital of Zhongshan | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH-a-1M | Active Comparator |
| |
| GnRH-a-2M | Active Comparator |
| |
| GnRH-a+LE-1M | Active Comparator |
| |
| GnRH-a+LE-2M | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH-a-1M | Drug | Pre-treatment with one dose GnRH agonist before endometrial preparation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | 40 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanwen Xu | Contact | +8613682213000 | xuyanwen@mail.sysu.edu.cn | |
| Yujing Xiong | Contact | +8618816899615 | xiongyj3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanwen Xu | Center for Reproductive Medicine, The First Affiliated Hospital of Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medical Center, the First Af liated Hospital of Sun Yat-sen University, Zhongshan 2nd Road, Number 1 | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22229256 | Result | 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. | |
| 24103533 | Result | 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. |
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only IPD used in the results publication
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| 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. |
|
| 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 |
| 34587658 | Result | 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. |
| 39274438 | Result | 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. |
| 26427702 | Result | 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. |
| 42032741 | Derived | 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. |
| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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