HemoglobinNCT02225145
Fertility Preservation in Women Who Will Have Gonadotoxic Therapy or Hematopoetic Stem Cell Transplantation, and in Women With Sickle Cell Disease
An observational study of Hemoglobin and Stem Cell Transplant, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 45 years
- Conditions the study is for
- Hemoglobin, Stem Cell Transplant, Aplastic Anemia
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2014to 20 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unable to comprehend the investigational nature of the protocol
- Positive pregnancy test
- Ovarian cancer
- Diagnosis of HIV/AIDS
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Hemoglobin, Stem Cell Transplant, Aplastic Anemia
- Keywords
- Bone Marrow Transplant, Fertility, Ovary
- Medical subject headings
- Anemia, Aplastic
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte vitrification
Measured: End of Stumulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start15 Aug 2014
- Primary completion9 Sep 2016
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemoglobinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alan H DeCherney, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225145
- Sponsor's protocol ID
- 140177
- Other IDs
- 14-CH-0177
- Status last verified
- 20 Sep 2017
- First submitted
- 23 Aug 2014
- Last updated
- 1 Jun 2018
- Results posted
- No
Publications
Practice Committees of the American Society for Reproductive Medicine and the 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.
PubMed 23083924Practice 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.
PubMed 24011612Dovey 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.
PubMed 22219083
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation in Females Who Will be Undergoing Gonadotoxic Therapy, Hematopoietic Stem Cell Transplantation, and in Females With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02225145
- Acronym / sponsor ID
- 140177
- Conditions
- Hemoglobin, Stem Cell Transplant, Aplastic Anemia
- Keywords
- Bone Marrow Transplant, Fertility, Ovary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 15 Aug 2014
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Unable to comprehend the investigational nature of the protocol
- Positive pregnancy test
- Ovarian cancer
- Diagnosis of HIV/AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oocyte vitrification
Time frame: End of Stumulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Background: PubMed 23083924Practice Committees of the American Society for Reproductive Medicine and the 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.
- Background: PubMed 24011612Practice 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.
- Background: PubMed 22219083Dovey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan H DeCherney, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobin and Stem Cell Transplant, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte vitrification (time frame: End of Stumulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225145, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.