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NCT01343368 · REGISTRY CONDITION SEARCH

Preservation of Ovarian Function After Hematopoietic Cell Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-12-05

Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Comparison of Number of Patients With Ovarian Failure

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outcome · POSTED

Comparison of Number of Patients Who Stopped Menstrual Bleeding

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outcome · POSTED

Comparison of Follicle Stimulating Hormone (FSH) Levels

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outcome · POSTED

Comparison of Follicle Stimulating Hormone (FSH) Levels

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outcome · POSTED

Comparison of Follicle Stimulating Hormone (FSH) Levels

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outcome · POSTED

Comparison of Follicle Stimulating Hormone (FSH) Levels

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outcome · POSTED

Comparison of Follicle Stimulating Hormone (FSH) Levels

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outcome · POSTED

Comparison of Number of Patients Who Resumed Menstrual Cycles

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outcome · POSTED

Comparison of Lutineizing Hormone (LH) Levels

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outcome · POSTED

Comparison of Luteinizing Hormone (LH) Levels

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outcome · POSTED

Comparison of Luteinizing Hormone (LH) Levels

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outcome · POSTED

Comparison of Luteinizing Hormone (LH) Levels

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outcome · POSTED

Comparison of Leuprolide Hormone (LH) Levels

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outcome · POSTED

Comparison of Antimullerian Hormone (AMH) Levels After Transplant

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outcome · POSTED

Comparison of Antimullerian Hormone (AMH) Levels After Transplant

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Interventional Arm: * Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT) * Post-menarchal female \< or = 50 years of age * Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty * Those women who have an FSH \> 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis. * Observational Arm: * Eligible for reduced intensity allogeneic HCT * Post-menarchal female ≤ 50 years of age * Normal AMH level and/or FSH/LH for age/stage of puberty * Those women who an FSH \>40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis. Exclusion Criteria: * All Arms: * History of ovarian cancer * Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact. * Use of GnRH agonist in last 12 months will exclude patients if lab results are not available to demonstrate adequate ovarian function prior to initiation of GnRH therapy.
healthy Volunteers
false
minimum Age
50 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
    intervention Names
    1. Drug: Leuprolide
    2. Biological: hematopoietic cell transplant
    label
    Interventional - Received Leuprolide
    type
    EXPERIMENTAL
  2. description
    Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
    intervention Names
    1. Biological: reduced intensity allogeneic HCT
    label
    Observational Arm
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Interventional - Received Leuprolide
    description
    Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
    name
    Leuprolide
    other Names
    1. Lupron Depot-3(R)
    2. Leuprolide acetate
    type
    DRUG
  2. arm Group Labels
    1. Interventional - Received Leuprolide
    description
    Conventional bone marrow transplant regimen.
    name
    hematopoietic cell transplant
    other Names
    1. HCT
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Observational Arm
    description
    A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
    name
    reduced intensity allogeneic HCT
    other Names
    1. RIC
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
19
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH \>40 IU/L) after transplant.
    measure
    Comparison of Number of Patients With Ovarian Failure
    time Frame
    Through Day 180 Post Transplant
secondary Outcomes
  1. description
    Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant
    measure
    Comparison of Number of Patients Who Stopped Menstrual Bleeding
    time Frame
    From Baseline Through Day 365
  2. description
    Comparison of treatment arms; interventional versus observational average FSH levels.
    measure
    Comparison of Follicle Stimulating Hormone (FSH) Levels
    time Frame
    Baseline
  3. description
    Comparison of treatment arms; interventional versus observational average FSH levels.
    measure
    Comparison of Follicle Stimulating Hormone (FSH) Levels
    time Frame
    Day 100
  4. description
    Comparison of treatment arms; interventional versus observational average FSH levels.
    measure
    Comparison of Follicle Stimulating Hormone (FSH) Levels
    time Frame
    Day 180
  5. description
    Comparison of treatment arms; interventional versus observational average FSH levels.
    measure
    Comparison of Follicle Stimulating Hormone (FSH) Levels
    time Frame
    1 year
  6. description
    Comparison of treatment arms; interventional versus observational average FSH levels.
    measure
    Comparison of Follicle Stimulating Hormone (FSH) Levels
    time Frame
    2 years
  7. description
    Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
    measure
    Comparison of Number of Patients Who Resumed Menstrual Cycles
    time Frame
    Day 365 Post Transplant
  8. description
    Comparison of treatment arms; interventional versus observational average LH levels during study.
    measure
    Comparison of Lutineizing Hormone (LH) Levels
    time Frame
    Baseline
  9. description
    Comparison of treatment arms; interventional versus observational average LH levels during study.
    measure
    Comparison of Luteinizing Hormone (LH) Levels
    time Frame
    Day 100
  10. description
    Comparison of treatment arms; interventional versus observational average LH levels during study.
    measure
    Comparison of Luteinizing Hormone (LH) Levels
    time Frame
    Day 180
  11. description
    Comparison of treatment arms; interventional versus observational average LH levels during study.
    measure
    Comparison of Luteinizing Hormone (LH) Levels
    time Frame
    1 year
  12. description
    Comparison of treatment arms; interventional versus observational average LH levels during study.
    measure
    Comparison of Leuprolide Hormone (LH) Levels
    time Frame
    2 years
Full study description
brief Summary
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.
detailed Description
This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women. The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure. The secondary objectives are * to determine how effective GnRH agonists are at suppressing menses during * to determine the incidence and timing of resumption of menstrual cycles after HCT * to determine the incidence and timing of resumption of normal FSH and LH levels after HCT * to determine the incidence of normal AMH levels after HCT * to determine the effect of GnRH agonists on immune reconstitution after HCT * to assess the safety and tolerability of GnRH agonists in the context of HCT A total of 47 patients will be accrued in this study.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      primary nct id
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-685e961da4cec1de8db6
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT01343368
        end
        11
        exact text
        NCT01343368
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2cbeffdf2716138ea0be37a0e93239e56fbc89718750c88bfd22e572e6080e95

    Preserved source evidence · Not medical advice