This study is currently recruiting participants.
Number
000106-CH
Sponsoring Institute
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Female Min Age: 4 Years Max Age: 21 Years
Referral Letter Required
No
Population Exclusion(s)
Male
Keywords
OVARIAN FUNCTION; follicle loss; Natural History
Recruitment Keyword(s)
None
Condition(s)
ovarian disfunction; post-menarcheal adolescents; Turner Syndrome; galactosemia
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Child Health and Human Development
Turner Syndrome, galactosemia, and premature ovarian insufficiency are all conditions that may make it very hard or impossible for a person to become pregnant and have their own child. Researchers want to learn more about why this happens and if freezing ovarian tissue allows for fertility preservation.
Objective:
To find out why females with certain conditions have can have premature ovarian insufficiency (POI or early menopause) and trouble getting pregnant and if freezing the tissue from their ovary will help them have their own child in the future.
Eligibility:
Females aged 4-12 who have Turner Syndrome or galactosemia. Also, females aged 13 21 with premature ovarian insufficiency.
Design:
Participants will be screened with a medical history.
Participants may have a physical exam and blood tests. Their body measurements may be taken. These include weight, height, arm span, skin fold, and sitting height. They may fill out surveys about their quality of life, body image, and health.
Participants may have a transabdominal pelvic ultrasound. A probe will be placed on their belly and will take pictures of the organs in the pelvis. They may have a transvaginal pelvic ultrasound performed while asleep in the operating room if needed.
Participants will have surgery to remove an ovary. The removed tissue will be frozen and stored. The tissue will have to be stored for many years. NIH will pay to store the tissue for 1 year. After that, participants will have to pay for storage.
A piece of the ovary (no more than 20%) will be used for research
Travel, lodging and meals for participants traveling greater than 50 miles will be reimbursed based off the government rate. Local participants will not be reimbursed.
Participants will have a checkup 6 weeks after surgery one or more follow-up visits 6 18 months after surgery. They may have phone follow-up every 12 24 months after surgery.
Participation will last 30 years.
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INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: - Individuals with Turner Syndrome and galactosemia prior to menarche aged 4 years to 12 years who have not demonstrated signs of premature ovarian insufficiency (one FSH>25 IU/L) whose families seek to store ovarian tissue for possible future use. Or - Children and adolescents who have Turner syndrome with Y material and undergo prophylactic gonadectomy. Or - Adolescent females up to age 21 years old, who have undergone menarche and are subsequently diagnosed with premature ovarian insufficiency and their last menstrual period occurred within 2 years of presentation. Diagnosis of POI is based on 2 elevated FSH concentrations obtained over 1 month apart. Or - Adolescents who have diminished ovarian reserve who respond poorly to ovarian stimulation for egg freezing. - Stated willingness to comply with all study procedures and availability for the duration of the study. - Ability of subject, parents or guardian to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: - Females older than 7 years with psychological, psychiatric, or other conditions which prevent giving fully informed consent or assent. - Females with a pelvic mass tumor noted on pre-operative ultrasound, will undergo usual care for the underlying condition and will not undergo oophorectomy for ovarian tissue cryopreservation - Females whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery. - Females with POI due to chemotherapy or radiation treatment - Pregnancy or lactation
In order to be eligible to participate in this study, an individual must meet all of the following
criteria:
- Individuals with Turner Syndrome and galactosemia prior to menarche aged 4 years to 12 years who have not demonstrated signs of premature ovarian insufficiency (one FSH>25 IU/L) whose families seek to store ovarian tissue for possible future use.
Or
- Children and adolescents who have Turner syndrome with Y material and undergo prophylactic gonadectomy.
- Adolescent females up to age 21 years old, who have undergone menarche and are subsequently diagnosed with premature ovarian insufficiency and their last menstrual period occurred within 2 years of presentation. Diagnosis of POI is based on 2 elevated FSH concentrations obtained over 1 month apart.
- Adolescents who have diminished ovarian reserve who respond poorly to ovarian stimulation for egg freezing.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability of subject, parents or guardian to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Females older than 7 years with psychological, psychiatric, or other conditions which prevent giving fully informed consent or assent.
- Females with a pelvic mass tumor noted on pre-operative ultrasound, will undergo usual care for the underlying condition and will not undergo oophorectomy for ovarian tissue cryopreservation
- Females whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
- Females with POI due to chemotherapy or radiation treatment
- Pregnancy or lactation
Principal Investigator
Referral Contact
For more information: