Premature Ovarian FailurePhase 1/2NCT02043743
Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure
A Phase 1/2 study testing Biological: Stem Cells in people with Premature Ovarian Failure, run by El-Rayadh Fertility Centre at 1 site in Egypt.
Trial summary
Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- Biological: Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Jan 2015
- Phase
- Phase 1/2
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with normal karyotype spontaneous premature ovarian failure.
- Patients between 18 - 40 years old.
Who cannot join
- Patients with secondary ovarian failure (e.g. hypothalamic causes).
- Pregnancy and lactation.
- Autoimmune diseases.
- Those with major medical problems such as malignancy, hepatitis, etc.
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome….).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
El-Rayadh Fertility Center
Giza
Hesham Elshaer, MD, +201223130881, dr.heshamelshaer@hotmail.com
About this study
Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism, and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer responding to circulating FSH by producing estrogen and developing fertile eggs) in women younger than 40 years. This condition occurs in approximately 1% of women and it has important physical and psychological consequences/impact in those patients.
The purpose of this study is to investigate the role of the transplantation of bone marrow derived stem cells into ovarian tissue for treatment of premature ovarian failure and to assess their ability to differentiate into germ cells.
Read the detailed description
This study is an open-label investigation of the efficacy of injection of autologous adult bone marrow derived stem cells into the ovarian stroma of patients with premature ovarian failure. Sixty women with premature ovarian failure will be recruited in this study after a written informed consent. Diagnosis will be based mainly on history taking, physical examination and investigations. Laboratory investigations will include Serum follicle-stimulating hormone (FSH), serum estrogen measurement and serum AMH. The anterior pituitary secretes FSH and LH at high levels due to the dysfunction of the ovaries and consequent low estrogen levels. Typical FSH in POF patients is over 40 mlU/ml (post-menopausal range). Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by a gynecological surgeon through a standard surgical approach (transvaginal U/S guided approach). Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one ovary only and the other ovary will be spared.
- Conditions
- Premature Ovarian Failure
- Being tested
- Biological: Stem Cells
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: Stem CellsBiological
Also called Stem Cells Transplantation
Biological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally 3-5 million MSCs injected into ovarian tissue.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory and Clinical | Experimental | Biological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
Stem Cell Dose:
•3-5 Million Autologous MSCs Injected into Ovarian tissue. Receives: Biological: Biological: Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cases Improvement
Decline in serum FSH level. Rise in serum estrogen level Elevation in serum AMH level
Measured: 48 Weeks
Secondary outcomes (1)
Cases Improvement
Disappearance of menopausal symptoms e.g. hot flashes Rise in serum AMH level. Pregnancy rate within 1 year. Miscarriage rate within one year of injection. Long term follow-up for any adverse effect, assessed for one year from injection.
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- El-Rayadh Fertility Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof.Dr. Hesham Elshaer, MD, Principal investigator, El-Rayadh Fertility CenterSayed Bakry, PhD, Study director, Al-Azhar UniversityWael Abu El Khier, MD, Study chair, Military AcademyHala Gabr, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043743
- Sponsor's protocol ID
- NCT0221012014
- Other IDs
- RFC0221012014
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure
- ClinicalTrials.gov ID
- NCT02043743
- Acronym / sponsor ID
- NCT0221012014
- Conditions
- Premature Ovarian Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- El-Rayadh Fertility CentreUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 23 Jan 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.
Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism, and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer responding to circulating FSH by producing estrogen and developing fertile eggs) in women younger than 40 years. This condition occurs in approximately 1% of women and it has important physical and psychological consequences/impact in those patients.
The purpose of this study is to investigate the role of the transplantation of bone marrow derived stem cells into ovarian tissue for treatment of premature ovarian failure and to assess their ability to differentiate into germ cells.
Detailed description
This study is an open-label investigation of the efficacy of injection of autologous adult bone marrow derived stem cells into the ovarian stroma of patients with premature ovarian failure. Sixty women with premature ovarian failure will be recruited in this study after a written informed consent. Diagnosis will be based mainly on history taking, physical examination and investigations. Laboratory investigations will include Serum follicle-stimulating hormone (FSH), serum estrogen measurement and serum AMH. The anterior pituitary secretes FSH and LH at high levels due to the dysfunction of the ovaries and consequent low estrogen levels. Typical FSH in POF patients is over 40 mlU/ml (post-menopausal range). Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by a gynecological surgeon through a standard surgical approach (transvaginal U/S guided approach). Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one ovary only and the other ovary will be spared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory and Clinical | Experimental | Biological: Biological: Stem CellsBiological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis. Stem Cell Dose: •3-5 Million Autologous MSCs Injected into Ovarian tissue. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with normal karyotype spontaneous premature ovarian failure.
- Patients between 18 - 40 years old.
Key exclusion criteria (5 listed)
- Patients with secondary ovarian failure (e.g. hypothalamic causes).
- Pregnancy and lactation.
- Autoimmune diseases.
- Those with major medical problems such as malignancy, hepatitis, etc.
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome….).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: Stem CellsAlso: Stem Cells TransplantationBiological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally 3-5 million MSCs injected into ovarian tissue. | Biological | Laboratory and Clinical |
Primary outcome
Cases Improvement
Time frame: 48 Weeks
Decline in serum FSH level. Rise in serum estrogen level Elevation in serum AMH level
1 secondary outcome
Cases Improvement
Time frame: 48 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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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.
Prof.Dr. Hesham Elshaer, MD principal investigator
El-Rayadh Fertility Center
Sayed Bakry, PhD study director
Al-Azhar University
Wael Abu El Khier, MD study chair
Military Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biological: Stem Cells in people with Premature Ovarian Failure, run by El-Rayadh Fertility Centre at 1 site in Egypt.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Jan 2014. 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 Egypt. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesham Elshaer, MD (+201223130881, dr.heshamelshaer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cases Improvement (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2014.