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
- 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.
- To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about the effects of these therapies.
- Women at least 18 years old who are past puberty and before menopause. They must be scheduled to have gonadotoxic therapies.
- 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.
|Condition or disease|
|Hemoglobin Stem Cell Transplant Aplastic Anemia|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||Fertility Preservation in Females Who Will be Undergoing Gonadotoxic Therapy, Hematopoietic Stem Cell Transplantation, and in Females With Sickle Cell Disease|
|Study Start Date :||August 15, 2014|
|Actual Primary Completion Date :||September 9, 2016|
|Actual Study Completion Date :||September 20, 2017|
- Oocyte vitrification [ Time Frame: End of Stumulation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225145
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Alan H DeCherney, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|