InfertilityNCT01702935
Ovarian Stem Cells From Women With Ovarian Insufficiency
An observational study of Infertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means that the ovaries are not able to function at a level appropriate for a woman's age. Previously, it was thought that women had only a fixed number of eggs that were lost each month until none were left at menopause. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2012to 21 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to give consent/assent to participate in the protocol.
- Listed below are acceptable medical conditions for inclusion in this protocol:
- Females older than 18 years with POI, POF, or DOR, undergoing ovarian biopsy by laparoscopy or clinically indicated abdominal surgery that provides access to the ovaries
- Clinical etiologies of POI may include, but are not limited to, idiopathic, autoimmune, chemotherapy related, or Turner s syndrome
- Subjects must have a diagnosis of premature ovarian failure or diminished ovarian reserve as defined by both:
- Early follicular phase FSH >15 IU/L
- AMH <0.16 ng/ml or below the level of detection for the assay used
- Females older than 18 years, with or without POI or POF, undergoing clinically indicated ovarian surgery
Who cannot join
- Unable to comprehend the investigational nature of the protocol participation
- Positive pregnancy test
- Anticoagulation or known coagulopathy
- Ovarian cancer
- History of a previous laparoscopy or laparotomy revealing abdominal adhesions that would preclude ovarian biopsy
- Previous bowel surgery.
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: Oogonial Stem Cell Isolation in Ovarian Insufficiency Patients
Background:
- Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means that the ovaries are not able to function at a level appropriate for a woman's age. Previously, it was thought that women had only a fixed number of eggs that were lost each month until none were left at menopause. However, recently, stem cells have been found in the ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells may help women with POI in the future. Researchers want to collect ovarian tissue from women with POI to investigate ovarian stem cells.
Read more
Objectives:
- To collect ovarian tissue from women with primary ovarian insufficiency.
Eligibility:
- Women between 18 and 50 years of age with primary ovarian insufficiency.
Design:
- Participants will be screened with a physical exam and medical history. They will also have a full gynecological exam. They will provide blood and urine samples.
- Participants will donate ovarian tissue for study. It will be collected through outpatient surgery. The surgery will take either half of an ovary or a full ovary.
- Treatment will not be provided as part of this study.
Read the detailed description
Early loss of human ovarian function results in a clinical condition known as primary ovarian insufficiency (POI) or premature ovarian failure (POF). This devastating condition renders women unable to have their own genetic child in more than 95% of cases (1), as well as failure of hormonal production by the ovary that is critical in maintaining bone health, restful sleep, and quality of life. Indeed, in more carefully designed studies where control groups were used, only 1.5% of POI patients became pregnant (2-8), which may more accurately represent the true fertility rate in this population. Currently, fertility treatments for these patients are primarily to use an egg donated from a young woman
Until recently, it was thought that women were born with a limited number of eggs, which were slowly depleted each month until exhaustion at the time of menopause. However, recent studies have suggested that new eggs can be made from adult stem cells in the ovary. (1, 2) These ovarian stem cells could be transplanted into a recipient mouse, who then delivered donor derived offspring (3). Recently, ovarian germline stem cell (i.e., oogonial stem cell) isolation has been reported from human ovaries (12).(4). However, it is not known if oogonial stem cell problems play a part in diseases such as premature ovarian failure or diminished ovarian reserve.
The goal of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency (POI)/failure (POF) and diminished ovarian reserve (DOR). There will be three groups in this study: patients with POI or POF undergoing ovarian biopsy by laparoscopy, patients with POI or POF undergoing clinically indicated abdominal surgery that provides access to the ovaries, and patients over 18 undergoing clinically indicated ovarian surgery (with or without POI or POF). Ovarian biopsies will be harvested by laparoscopy or at the time of indicated surgery, and oogonial stem cells will be isolated in the laboratory and characterized.
- Conditions
- Infertility
- Keywords
- Ovarian Failure, Premature Ovarian Failure, Infertility, Primary Ovarian Insufficiency, Stem Cells
- Medical subject headings
- Infertility, Primary Ovarian Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study start19 Sep 2012
- Study completion21 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 InfertilityStudies 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
- Time perspective
- Prospective
- Enrolment
- 11 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
- NCT01702935
- Sponsor's protocol ID
- 120212
- Other IDs
- 12-CH-0212
- Status last verified
- 21 Sep 2017
- First submitted
- 6 Oct 2012
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
van Kasteren YM, Schoemaker J. Premature ovarian failure: a systematic review on therapeutic interventions to restore ovarian function and achieve pregnancy. Hum Reprod Update. 1999 Sep-Oct;5(5):483-92. doi: 10.1093/humupd/5.5.483.
PubMed 10582785Anasti JN, Kimzey LM, Defensor RA, White B, Nelson LM. A controlled study of danazol for the treatment of karyotypically normal spontaneous premature ovarian failure. Fertil Steril. 1994 Oct;62(4):726-30. doi: 10.1016/s0015-0282(16)56996-9.
PubMed 7926080Nelson LM, Kimzey LM, White BJ, Merriam GR. Gonadotropin suppression for the treatment of karyotypically normal spontaneous premature ovarian failure: a controlled trial. Fertil Steril. 1992 Jan;57(1):50-5. doi: 10.1016/s0015-0282(16)54775-x.
PubMed 1730330
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oogonial Stem Cell Isolation in Ovarian Insufficiency Patients
- ClinicalTrials.gov ID
- NCT01702935
- Acronym / sponsor ID
- 120212
- Conditions
- Infertility
- Keywords
- Ovarian Failure, Premature Ovarian Failure, Infertility, Primary Ovarian Insufficiency, Stem Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 19 Sep 2012
- Study completion
- 21 Sep 2017
- First posted
- 10 Oct 2012 (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:
- Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means that the ovaries are not able to function at a level appropriate for a woman's age. Previously, it was thought that women had only a fixed number of eggs that were lost each month until none were left at menopause. However, recently, stem cells have been found in the ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells may help women with POI in the future. Researchers want to collect ovarian tissue from women with POI to investigate ovarian stem cells.
Objectives:
- To collect ovarian tissue from women with primary ovarian insufficiency.
Eligibility:
- Women between 18 and 50 years of age with primary ovarian insufficiency.
Design:
- Participants will be screened with a physical exam and medical history. They will also have a full gynecological exam. They will provide blood and urine samples.
- Participants will donate ovarian tissue for study. It will be collected through outpatient surgery. The surgery will take either half of an ovary or a full ovary.
- Treatment will not be provided as part of this study.
Detailed description
Early loss of human ovarian function results in a clinical condition known as primary ovarian insufficiency (POI) or premature ovarian failure (POF). This devastating condition renders women unable to have their own genetic child in more than 95% of cases (1), as well as failure of hormonal production by the ovary that is critical in maintaining bone health, restful sleep, and quality of life. Indeed, in more carefully designed studies where control groups were used, only 1.5% of POI patients became pregnant (2-8), which may more accurately represent the true fertility rate in this population. Currently, fertility treatments for these patients are primarily to use an egg donated from a young woman
Until recently, it was thought that women were born with a limited number of eggs, which were slowly depleted each month until exhaustion at the time of menopause. However, recent studies have suggested that new eggs can be made from adult stem cells in the ovary. (1, 2) These ovarian stem cells could be transplanted into a recipient mouse, who then delivered donor derived offspring (3). Recently, ovarian germline stem cell (i.e., oogonial stem cell) isolation has been reported from human ovaries (12).(4). However, it is not known if oogonial stem cell problems play a part in diseases such as premature ovarian failure or diminished ovarian reserve.
The goal of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency (POI)/failure (POF) and diminished ovarian reserve (DOR). There will be three groups in this study: patients with POI or POF undergoing ovarian biopsy by laparoscopy, patients with POI or POF undergoing clinically indicated abdominal surgery that provides access to the ovaries, and patients over 18 undergoing clinically indicated ovarian surgery (with or without POI or POF). Ovarian biopsies will be harvested by laparoscopy or at the time of indicated surgery, and oogonial stem cells will be isolated in the laboratory and characterized.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is able to give consent/assent to participate in the protocol.
- Females older than 18 years with POI, POF, or DOR, undergoing ovarian biopsy by laparoscopy or clinically indicated abdominal surgery that provides access to the ovaries
- Females older than 18 years, with or without POI or POF, undergoing clinically indicated ovarian surgery
Key exclusion criteria (6 listed)
- Unable to comprehend the investigational nature of the protocol participation
- Positive pregnancy test
- Anticoagulation or known coagulopathy
- Ovarian cancer
- History of a previous laparoscopy or laparotomy revealing abdominal adhesions that would preclude ovarian biopsy
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
The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.
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 17 Dec 2019.
- Background: PubMed 10582785van Kasteren YM, Schoemaker J. Premature ovarian failure: a systematic review on therapeutic interventions to restore ovarian function and achieve pregnancy. Hum Reprod Update. 1999 Sep-Oct;5(5):483-92. doi: 10.1093/humupd/5.5.483.
- Background: PubMed 7926080Anasti JN, Kimzey LM, Defensor RA, White B, Nelson LM. A controlled study of danazol for the treatment of karyotypically normal spontaneous premature ovarian failure. Fertil Steril. 1994 Oct;62(4):726-30. doi: 10.1016/s0015-0282(16)56996-9.
- Background: PubMed 1730330Nelson LM, Kimzey LM, White BJ, Merriam GR. Gonadotropin suppression for the treatment of karyotypically normal spontaneous premature ovarian failure: a controlled trial. Fertil Steril. 1992 Jan;57(1):50-5. doi: 10.1016/s0015-0282(16)54775-x.
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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 Infertility, 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 8 inclusion and 6 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 17 Dec 2019. 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?
The immediate aim of this protocol is to characterize oogonial stem cells in patients with primary ovarian insufficiency and diminished ovarian reserve.. 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 NCT01702935, 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 17 Dec 2019.