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

May 31, 2018 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Fertility Preservation in Females Who Will be Undergoing Gonadotoxic Therapy, Hematopoietic Stem Cell Transplantation, and in Females With Sickle Cell Disease

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oocyte vitrification
Time Frame: End of Stumulation
End of Stumulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 15, 2014

Primary Completion (Actual)

September 9, 2016

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

August 23, 2014

First Submitted That Met QC Criteria

August 23, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

September 20, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140177
  • 14-CH-0177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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