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HSCT is an effective method to cure hematologic malignancies. However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of life of patients. This clinical trial aimed to observe the effect of Gonadotropin-releasing hormone analogues (GnRHa) on ovarian function in women of reproductive age after HSCT, so as to provide clinical evidence for whether GnRHa should be used for the prevention of POF.
Hematopoietic stem cell transplantation (HSCT) is an effective method for the treatment of hematologic malignancies. However, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (POF), seriously affecting the long-term quality of life of patients. Exogenous injection of gonadotropin-releasing hormone analogue (GnRHa) has a significant effect on fertility preservation in adolescent and reproductive female patients with breast cancer and cervical cancer. However, there is a lack of large-scale clinical studies on POF in HSCT. Therefore, this clinical trial aimed to observe the effect of GnRHa application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether GnRHa application for fertility function protection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leprorelin group | Experimental | Leprorelin was given subcutaneously before each cycle of chemotherapy. |
|
| Control group | Placebo Comparator | Normal salinewas given subcutaneously before each cycle of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leuprorelin | Drug | From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of leprorelin in each cycle of chemotherapy including the conditioning treatment prior to transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| POF rate | Incidence of premature ovarian failure after transplantation | three years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| acute GVHD rate | the incidence of acute graft-versus-host disease (GVHD) | At day 100 post-transplantation |
| chronic GVHD rate | the incidence of chronic graft-versus-host disease (GVHD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoning Wang, MD | Contact | 0086-18991232608 | wangxn99@163.com | |
| Xiaoyan Zheng, MD | Contact | 0086-15829370502 | xiaoy_2008@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoning Wang, MD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
| normal saline | Drug | From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of normal saline in each cycle of chemotherapy including the conditioning treatment prior to transplantation. |
|
|
| From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months. |
| PFS | Progression Free Survival | From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months. |
| OS | Overall Survival | From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months. |
| AEs | Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions. | up to 6 months after HSCT |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |