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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

NCT02225145 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2018-06-01

No results posted yet for this study

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.

Conditions

  • Hemoglobin
  • Stem Cell Transplant
  • Aplastic Anemia

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Alan H DeCherney, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
7 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-15
Primary Completion
2016-09-09
Completion
2017-09-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225145 on ClinicalTrials.gov