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Fertility Preservation in Women Who Will Have Gonadotoxic Therapy or Hematopoetic Stem Cell Transplantation, and in Women With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02225145
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Tracking Information
First Submitted Date August 23, 2014
First Posted Date August 26, 2014
Last Update Posted Date June 1, 2018
Study Start Date August 15, 2014
Actual Primary Completion Date September 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2014)
Oocyte vitrification [ Time Frame: End of Stumulation ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fertility Preservation in Women Who Will Have Gonadotoxic Therapy or Hematopoetic Stem Cell Transplantation, and in Women With Sickle Cell Disease
Official Title Fertility Preservation in Females Who Will be Undergoing Gonadotoxic Therapy, Hematopoietic Stem Cell Transplantation, and in Females With Sickle Cell Disease
Brief Summary

Background:

- Some treatments for cancer or other diseases can lead to infertility in women. These treatments include chemotherapy, some stem cell transplants, and pelvic radiotherapy. They are called gonadotoxic therapies. Women can now have their eggs frozen before they have these treatments. This may allow them to get pregnant later. Researchers want to learn more about this technology and processes.

Objectives:

- To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about the effects of these therapies.

Eligibility:

- Women at least 18 years old who are past puberty and before menopause. They must be scheduled to have gonadotoxic therapies.

Design:

  • Participants will be screened with medical history and blood and hormone tests. They will also have a physical exam and transvaginal ultrasound.
  • Ovary stimulation: participants will have medications injected under the skin. These increase the chance of fertility. This phase will take about 8 20 days. Participants will have blood drawn and transvaginal ultrasound daily or every other day. Some participants will also have blood thinner injected daily.
  • Egg retrieval: participants will check in to the hospital. Eggs will be removed with a needle during a short surgery. Participants will be awake but sedated.
  • Participants may stay overnight in the hospital.
  • They will return every 1 3 days for 1 3 weeks for blood tests.
  • Mature eggs will be frozen after egg retrieval and immature eggs (which cannot be fertilized for clinical use) will be used for research. Participants can use their eggs in the future at outside, private fertility clinics to try to become pregnant. If the eggs are stored for more than 5 years, participants must pay for storage.
Detailed Description Treatment with chemotherapeutic drugs, hematopoietic stem cell transplantation, and pelvic radiotherapy for cancer or other serious medical illnesses has the potential to markedly increase the risk of gonadotoxicity leading to infertility in women. Females who are post-menarchal with these risk factors may be candidates for fertility preservation through oocyte cryopreservation before ovarian failure ensues. For example, sickle cell disease (SCD) is the most common hemoglobinopathy in the United States (3). Hypoxic conditions cause the abnormal hemoglobin molecule to undergo sickling which leads to painful microvascular occlusion. SCD is associated with multiple organ system dysfunction as well as neurological and pulmonary complications, which can lead to early mortality. Hematopoietic stem cell transplantation (HSCT) is the only treatment currently available for SCD that results in a complete cure. In patients who have undergone HSCT with a matched sibling, event-free survival has been as high as 85%-95%. Multiple studies have unfortunately demonstrated that infertility and premature ovarian insufficiency are quite common following HSCT. Specifically in our patient population with sickle cell disease, we have recently found largely preserved ovarian function prior to transplantation, but profound gonadotoxicity following transplant (unpublished). This underscores the clinical need for additional, effective fertility preservation methods for our at-risk populations.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Hemoglobin
  • Stem Cell Transplant
  • Aplastic Anemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 15, 2016)
22
Original Estimated Enrollment
 (submitted: August 23, 2014)
10
Actual Study Completion Date September 20, 2017
Actual Primary Completion Date September 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:

Subject is able to give consent/assent to participate in the protocol:

  • Post-Menarchal females greater than or equal to 7 years old undergoing gonadotoxic therapy, hematopoietic stem cell transplantation, and/or sickle cell disease
  • Have a FSH less than or equal to 13 mIU/ml or AMH greater than or equal to 0.5 ng/ml

EXCLUSION CRITERIA:

  • Unable to comprehend the investigational nature of the protocol
  • Positive pregnancy test
  • Ovarian cancer
  • Diagnosis of HIV/AIDS
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02225145
Other Study ID Numbers 140177
14-CH-0177
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators Not Provided
Investigators
Principal Investigator: Alan H DeCherney, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 20, 2017