Aplastic Anemia Clinical Trial
Official title:
Fertility Preservation in Females Who Will be Undergoing Gonadotoxic Therapy, Hematopoietic Stem Cell Transplantation, and in Females With Sickle Cell Disease
Verified date | September 20, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | September 20, 2017 |
Est. primary completion date | September 9, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 45 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Dovey S, Krishnamurti L, Sanfilippo J, Gunawardena S, Mclendon P, Campbell M, Alway S, Efymow B, Gracia C. Oocyte cryopreservation in a patient with sickle cell disease prior to hematopoietic stem cell transplantation: first report. J Assist Reprod Genet. 2012 Mar;29(3):265-9. doi: 10.1007/s10815-011-9698-2. Epub 2012 Jan 5. — View Citation
Practice Committee of American Society for Reproductive Medicine. Fertility preservation in patients undergoing gonadotoxic therapy or gonadectomy: a committee opinion. Fertil Steril. 2013 Nov;100(5):1214-23. doi: 10.1016/j.fertnstert.2013.08.012. Epub 2013 Sep 5. — View Citation
Practice Committees of American Society for Reproductive Medicine; Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013 Jan;99(1):37-43. doi: 10.1016/j.fertnstert.2012.09.028. Epub 2012 Oct 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oocyte vitrification | End of Stumulation |
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