A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT

NCT05667428 | Unknown

• 1 other identifier: XJTU1AF-CRF-2022-XK002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic Stem Cell Transplantation; Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

• POF rate

  Incidence of premature ovarian failure after transplantation

  three years after transplantation

Secondary Outcomes (5)

• acute GVHD rate

  At day 100 post-transplantation

• chronic GVHD rate

  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

  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

  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

  up to 6 months after HSCT

Study Arms (2)

Leprorelin group

EXPERIMENTAL

Leprorelin was given subcutaneously before each cycle of chemotherapy.

Drug: leuprorelin

Control group

PLACEBO COMPARATOR

Normal salinewas given subcutaneously before each cycle of chemotherapy.

Drug: normal saline

Interventions

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.

Also known as: GnRHa

Leprorelin group

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.

Also known as: NS

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with acute leukemia, MDS, lymphoma, multiple myeloma, SAA and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation.
• Female, aged 18-45 years.
• Ovarian function was normal before treatment.
• Volunteer to participate in clinical research and sign the informed consent form.

You may not qualify if:

• No menstruation before treatment, undergone hysterectomy or ovarian surgery.
• Abnormal sexual development.
• Received radiotherapy.
• Combined with tumors affecting gonadal function.
• Deep vein thrombosis.
• Hypertension, liver and/or kidney dysfunction cannot tolerate hematopoietic stem cell transplantation.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Leuprolide; Saline Solution

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xiaoning Wang, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoning Wang, MD

CONTACT

0086-18991232608; wangxn99@163.com

Xiaoyan Zheng, MD

CONTACT

0086-15829370502; xiaoy_2008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: December 28, 2022
• Study Start: March 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 23, 2023

Record last verified: 2022-10

Locations

CN (1)