Clinical trial NCT02043743: Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure
Official title: Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Premature Ovarian Failure
Lead sponsor: El-Rayadh Fertility Centre
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Patients with normal karyotype spontaneous premature ovarian failure.
* Patients between 18 - 40 years old.

Exclusion Criteria:

* 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....).

Primary outcomes:
measure: Cases Improvement
timeFrame: 48 Weeks
Secondary outcomes:
measure: Cases Improvement
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: El-Rayadh Fertility Center
Study officials:
affiliation: El-Rayadh Fertility Center
name: Prof.Dr. Hesham Elshaer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Sayed Bakry, PhD
role: STUDY_DIRECTOR
affiliation: Military Academy
name: Wael Abu El Khier, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hala Gabr, MD
role: STUDY_CHAIR
References: