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Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure (POF)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02151890
Acronym
POF
Enrollment
10
Registered
2014-06-02
Start date
2012-03-31
Completion date
2014-05-31
Last updated
2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ovarian Failure

Keywords

POF, ESS, stem cell

Brief summary

Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established in 10 cases. ESS cut off point for menstruation and pregnancy was 6.

Detailed description

Out of 112 high risk patients for POF, diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by immubohistchemical (IH) staining by stem cell marker OCT4. IH expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Score (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS). These cases were of ESS 5 and 6.

Interventions

BIOLOGICALStem Cell

Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Post-menarche female less than 40 years old. * Normal karyotyping female. * Primary ovarian failure females * Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L. * Agree to sign the designed consent for the study.

Exclusion criteria

* Autoimmune diseases. * Breast cancer, ovarian cancer. * Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs. * Those with major medical problems such as malignancy, hepatitis, etc.

Design outcomes

Primary

MeasureTime frameDescription
Pregnancy104 weeksHormonal analysis

Secondary

MeasureTime frameDescription
Menstruation104 weeksClinical

Other

MeasureTime frameDescription
Ovulation104 weeksUltrasound

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026