1. Home
  2. Approved trials
  3. » فارسی

Evaluating the effects of allogeneic transplantation of umbilical cord- derived mesenchymal stem cells combination with in vitro activation (IVA) technique on improvement of ovarian function and fertility outcomes in women with premature ovarian failure (POF)- Clinical trials phase I

Protocol summary

Study aim
Evaluating the effects of allogeneic transplantation of umbilical cord- derived mesenchymal stem cells combination with in vitro activation (IVA) technique on improvement of ovarian function and fertility outcomes in women with premature ovarian failure
Design
Clinical trial phase I without control group on 10 patients
Settings and conduct
Isolation and expansion of stem cells: Motahari hospital clean room in Iran University of Medical Sciences Implantation of stem cells and invitro activation operation: Razi hospital in Guilan University of Medical Sciences, Ghaem international hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women aged 18 to 40 years old; Normal karyotyping female; Diagnosed with Premature Ovarian Failure: Serum FSH > 20 IU/l, AMH < 0.3 ng /mL; Normal TSH; Agree to sign the designed consent for the study. Exclusion Criteria: Thyroid dysfunction; Immunological Conditions; Past history of malignancy/chemotherapy/radiotherapy; Infectious diseases: HIV+, hepatitis B+, C+; Abnormal karyotype; Previous surgical management of ovarian pathology; Severe endometriosis; Breast cancer, ovarian cancer; Severe pulmonary, kidney and hematological disease, diabetes (type I,II), Severe anemia (Hemoglobin <8 g/dL).
Intervention groups
Transplantation of of umbilical cord- derived mesenchymal stem cells into ovaries combination with in vitro activation (IVA) technique
Main outcome variables
FSH serum level, AMH serum level, Estradiol serum level, Menstrual cycle, Menopausal symptoms, Number and size of ovarian follicles, Endometrial thickness, Natural conception rate or consequent assisted reproductive techniques (ART)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211021052828N1
Registration date: 2021-11-14, 1400/08/23
Registration timing: prospective

Last update: 2021-11-14, 1400/08/23
Update count: 0
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Elham Vojoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 4270
Email address
elhamvojoodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2023-08-16, 1402/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of allogeneic transplantation of umbilical cord- derived mesenchymal stem cells combination with in vitro activation (IVA) technique on improvement of ovarian function and fertility outcomes in women with premature ovarian failure (POF)- Clinical trials phase I
Public title
The Safety and Efficacy study of IVA technique Combined Stem Cell Therapy (IVASc) in Patients With Premature Ovarian Failure (POF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal karyotyping female Diagnosed with Premature Ovarian Failure: Serum FSH > 20 IU/l, AMH < 0.3 ng /mL Normal TSH Agree to sign the designed consent for the study women aged 18 to 40 years old
Exclusion criteria:
Thyroid dysfunction Immunological Conditions Past history of malignancy/cemotherapy/radiotherapy Infectious diseases: HIV+, hepatitis B+, C+ Abnormal karyotype Previous surgical management of ovarian pathology Severe endometriosis Breast cancer, ovarian cancer Severe pulmonary, kidney and hematological disease, diabetes (type I,II), ... Severe anemia (Hemoglobin <8 g/dL)
Age
From 18 years old to 40 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan University of Medical sciences
Street address
Ershad St, Ansari Blv, Rasht Town
City
Rasht
Province
Guilan
Postal code
417861311
Approval date
2021-10-13, 1400/07/21
Ethics committee reference number
IR.GUMS.REC.1400.325

Health conditions studied

1

Description of health condition studied
Premature Ovarian Failure (POF)
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure

Primary outcomes

1

Description
Get regular periods naturally
Timepoint
Before intervention and 3, 6 and 12 months after intervention
Method of measurement
consultation

2

Description
Decrease FSH serum level
Timepoint
Before intervention and 3, 6 and 12 months after intervention
Method of measurement
Serum level of hormone

3

Description
Increase Estradiol serum level
Timepoint
Before intervention and 3, 6 and 12 months after intervention
Method of measurement
Serum level of hormone

4

Description
Increase AMH serum level
Timepoint
Before intervention and 3, 6 and 12 months after intervention
Method of measurement
Serum level of hormone

5

Description
, Increase of number and size of ovarian follicles
Timepoint
Before intervention and 3, 6 and 12 months after intervention
Method of measurement
, Sonography of follicle number and size

6

Description
افزایش ضخامت اندومتر
Timepoint
Before intervention and 3, 6 and 12 months after intervention
Method of measurement
Sonography of endometrial thickness

7

Description
Natural conception or conceive Assisted reproductive technology (ART)
Timepoint
Before intervention and 3, 6 and 12 months after intervention
Method of measurement
Consultation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Invitro activation (IVA) and stem cell transplantation
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem international hospital
Full name of responsible person
Dr. Marieh Mehrafza
Street address
Shahid Eftekhari Blv.
City
Rasht
Province
Guilan
Postal code
4159658866
Phone
+98 13 3375 5353
Fax
+98 13 3376 4257
Email
Marzieh.mehrafza@gmail.com

2

Recruitment center
Name of recruitment center
Razi University Hospital
Full name of responsible person
Dr. Elham Vojoudi
Street address
Mirza Kuchak Khan Jangali Ave.
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 1001
Fax
+98 13 3355 9787
Email
elhamvojoodi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mehr medical Institute
Full name of responsible person
Dr. Marzieh Mehrafza
Street address
Ershad St, Ansari Blv
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3375 5353
Fax
+98 13 3376 4257
Email
marzieh.mehrafza@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehr medical Institute
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Elham Vojoudi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Ershad St, Ansari Blv
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Email
elhamvojoodi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Dr. Elham Vojoudi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Mirza Kuchik Khan Ave.
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3375 5353
Fax
+98 13 3376 4257
Email
elhamvojoodi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Dr. Elham Vojoudi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Mirza Kuchik Khan Ave.
City
Rasht
Province
Guilan
Postal code
4144985655
Phone
+98 13 3375 5353
Fax
+98 13 3376 4257
Email
elhamvojoodi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...