Protocol summary

Summary
The essential role of ooplasm in maturing and activating oocytes and in the primary stages of embryonic division is well documented; however, little is known about the details of this process. Cohen et al. (1997) first reported successful human impregnation after transferring the cytoplasm of the donated oocytes to those of the infertile women. Their objective was to restore the normal growth of high-risk oocytes caused by ooplasmic defect. They also reported the birth of over 30 healthy babies by the end of 2004 by the direct injection of the cytoplasm from donated (either frozen or fresh) oocytes to defective ones using modified ICSI. This technique includes the injection of 10-15% of the cytoplasm from a donated oocyte to a target oocyte in order to enhance its genesis under laboratory conditions.The cytoplasm of a mature oocyte can lead to the maturity of a defective oocyte, due to having regulators of cell cycle, healthy mitochondria, microtubules involved in cell division, DNA replication enzymes, and enhancing the level of mRNA. This technique can be used for women who have had repeated IVF failure or unsuccessful implantation due to poor quality embryos in their previous cycles. According to the studies conducted on the expression levels of genes involved in the natural trend of development and evolution of human oocyte, the present study aims to evaluate the changes in the expression of genes that occur in an oocyte after cytoplasmic injection and compare its results to the oocytes in the control group. It is noteworthy that the present study will be conducted on available oocytes whose usage will not pose any ethical considerations, including donated and immature oocytes. In the present work, immature oocytes will be categorized into two categories: 1- 30 immature oocytes as the intervention group: 15% cytoplasm in injected to them; afterwards, they will be cultivated in G1 medium culture and kept in incubator for 24 hours. Then, Trizol solution will be added to them and they will be kept at -80 °C. 2- 60 immature oocytes as the control group, which itself is further categorized into two groups: a. 30 immature oocytes will be put in the Trizol solution immediately after pick up, and will be kept at -80 °C. b. 30 immature oocytes will be cultivated in in G1 medium culture and kept in incubator for 24 hours. Then, Trizol solution will be added to them and they will be kept at -80 °C. After the sampling, the oocytes in each group will be pooled separately. Then, their RNA will be extracted and cDNA will be synthesized. Finally, the expression level of target genes will be determined using the Q RT-PCR in each group. The level of morphological changes in the oocytes of each group (both intervention and control) will also be determined after 24 hours of incubation using inverted microscope.

General information

Acronym
human immature oocyte and ooplasmic transfer
IRCT registration information
IRCT registration number: IRCT2013090512307N1
Registration date: 2013-09-05, 1392/06/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-05, 1392/06/14
Registrant information
Name
Fatemeh Sadat Hoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 7062
Email address
fshoseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-20, 1392/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of gene expression of immature oocytes before and after Ooplasmic transfer in Unexplained Infertile women in Mirza kochak Khan Hospital(2012-2013)
Public title
Comparison of gene expression of immature oocytes before and after Ooplasmic transfer in Unexplained Infertile women in Mirza kochak Khan Hospital(2012-2013)
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: age 18-40 yrs; normal level of serum FSH/ LH/ PRL/ TSH; persistent mature and immature oocytes at OPU; long agonist protocol ovarian stimulation; mild endometriosis-Male Infertility-Un Explained Infertility-Tubal Factor. Exclusion criteria: PCO; moderate/severe Endometriosis and Genetic diseases.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of Research of Tehran University of Medical Science
Street address
Floor 6th,Deputy of Research of Tehran University of Medical Science,Ghods street,Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2012-10-21, 1391/07/30
Ethics committee reference number
130/1743/د/91

Health conditions studied

1

Description of health condition studied
IVF, ART
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of ooplasm transfer into immature oocytes on the gene expression of TGF-B family
Timepoint
end of sampling
Method of measurement
Real Time PCR

2

Description
The effect of ooplasm transfer into immature oocytes on the gene expression of cycle cell
Timepoint
end of sampling
Method of measurement
Real Time PCR

3

Description
The effect of ooplasm transfer into immature oocytes on the gene expression of apoptosis
Timepoint
end of sampling
Method of measurement
Real Time PCR

4

Description
The effect of ooplasm transfer into immature oocytes on the gene expression of ATPase 6 in mitcondria
Timepoint
end of sampling
Method of measurement
Real Time PCR

5

Description
The effect of ooplasm transfer into immature oocytes on the gene expression of DNA repairing
Timepoint
end of sampling
Method of measurement
Real Time PCR

6

Description
The effect of ooplasm transfer into immature oocytes on the gene expression of mitotic spindle
Timepoint
end of sampling
Method of measurement
Real Time PCR

Secondary outcomes

1

Description
The effect of ooplasm transfer into immature oocytes on the morphology after24 hrs oocyte incubation
Timepoint
24 hrs after oocytes culture
Method of measurement
Invert Microscope

Intervention groups

1

Description
human Ooplasm Transfer 10-15% to immature oocytes and then oocytes culture for 24 hours in 5% co2 incubator.
Category
Other

2

Description
control group 1,not intervention
Category
Other

3

Description
control group 2,oocytes culture for 24 hours in 5% co2 incubator
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mirza Kochak Khan Hospital
Full name of responsible person
Dr. Naser Salsabili Dr. firoozeh Akbari Asbagh
Street address
North Negatollahi ST.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Akbar Fotohi
Street address
Floor 6th, Deputy of Research of Tehran University of Medical Science, Ghods street, Keshavarz Blvd.
City
Tehran
Grant name
پایان نامه دکترای تخصصی
Grant code / Reference number
91023018324
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Noori Mugahi
Position
prof. of Histology & Embryology
Other areas of specialty/work
Street address
Histology Department,Faculty of Medcine. Poor Sina street,Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8895 3008
Fax
Email
Noorimoo@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Teran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hoseini
Position
Research Employee and Student PhD of Reproductive Biology
Other areas of specialty/work
Street address
Floor 6th,Deputy of Research of Tehran University of Medical Science,Ghods street,Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3623
Email
fshoseini@razi.tums.ac.ir; hoseini_fs@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hoseini
Position
Reasearch emploee and candidate of PhD of Reproductive Biology
Other areas of specialty/work
Street address
Floor 6th, Deputy of Research of Tehran University of Medical Sciences, Ghods street, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8163 3619
Fax
Email
fshoseini@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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