NCT02225145

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
Last Updated

June 1, 2018

Status Verified

September 20, 2017

Enrollment Period

2.1 years

First QC Date

August 23, 2014

Last Update Submit

May 31, 2018

Conditions

HemoglobinStem Cell TransplantAplastic Anemia

Keywords

Bone Marrow TransplantFertilityOvary

Outcome Measures

Primary Outcomes (1)

  • Oocyte vitrification

    End of Stumulation

Eligibility Criteria

Age7 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to comprehend the investigational nature of the protocol
  • Positive pregnancy test
  • Ovarian cancer
  • Diagnosis of HIV/AIDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 23083924BACKGROUND

  • 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.

    PMID: 24011612BACKGROUND

  • 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.

    PMID: 22219083BACKGROUND

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

Study Officials

  • Alan H DeCherney, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2014

First Posted

August 26, 2014

Study Start

August 15, 2014

Primary Completion

September 9, 2016

Study Completion

September 20, 2017

Last Updated

June 1, 2018

Record last verified: 2017-09-20

Locations

US(1)