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Protocol summary
The inclusion criteria: < 40 yr old, in POSEIDON group III or IV , AFC<5 ,AMH< 1.2 ng/dl,FSH levels < 10 IU/L with a history of at least one failed stimulation cycle resulting in the inability to retrieve oocyte. Participants with male factor infertility and positive history of hydrosalpinx or anatomical uterine disorders and endocrine disease were excluded from the study.
The inclusion criteria: < 40 yr old, in POSEIDON group III or IV , AFC<5 ,AMH< 1.2 ng/dl,FSH levels < 10 IU/L with a history of at least one failed stimulation cycle resulting in the inability to retrieve oocyte. Participants with male factor infertility and positive history of hydrosalpinx or anatomical uterine disorders and endocrine disease were excluded from the study
The inclusion criteria: < 40 yr old, in POSEIDON group III or IV , AFC<5 ,AMH< 1.2 ng/dl,FSH levels < 10 IU/L with a history of at least one failed stimulation cycle resulting in the inability to retrieve oocyte. Participants with male factor infertility and positive history of hydrosalpinx or anatomical uterine disorders and endocrine disease were excluded from the study.
The count of retrieved oocytes,
number of oocytes metaphase II,
the quantity of embryos transferred,
implantation rate
clinical pregnancy rate.
The count of retrieved oocytes,
number of oocytes metaphase II
the number andc quantity of embryos transferred
implantation rate
clinical pregnancy rate.
The count of retrieved oocytes, number of oocytes metaphase II, the number andc quantity of embryos transferred, implantation rate clinical pregnancy rate.
تعداد تخمک‌های بازیابی شده،
تعداد تخمک‌های متافاز 2
، تعداد جنین‌های منتقل‌شده،
میزان لانه‌گزینی
نرخ حاملگی بالینی
تعداد تخمک‌های بازیابی شده،
تعداد تخمک‌های متافاز 2
، تعداد جنین‌های منتقل‌شده،
تعداد وکیفیت جنین های منتقل شده
میزان لانه‌گزینی
نرخ حاملگی بالینی
تعداد تخمک‌های بازیابی شده، تعداد تخمک‌های متافاز 2 ، تعداد جنین‌های منتقل‌شده، تعداد وکیفیت جنین های منتقل شده میزان لانه‌گزینی نرخ حاملگی بالینی
General information
10
15
1015
empty
10
10
empty
2023-05-01, 1402/02/11
2023-05-01 00:00:00
empty
2023-09-22, 1402/06/31
2023-09-22 00:00:00
empty
2023-12-21, 1402/09/30
2023-12-21 00:00:00
Due to the initial registration in the work study system, the clinical trial and the completion of the collection of samples, follow-up of patients and analysis of the obtained results, updating is done in the system.
According to the pilot study, according to the co-worker's discretion, the sample size increased from 6 to 10 cases.
Due to the completion of the final statistical results and completion of the results, the system was updated.
Due to the initial registration in the work study system, the clinical trial and the completion of the collection of samples, follow-up of patientsfinal statistical results and analysiscompletion of the obtained results, updating is done in the system was updated. According to the pilot study, according to the co-worker's discretion, the sample size increased from 6 to 10 cases.
بعلت ثبت اولیه در سامانه مطالعه کارآزمایی بالینی واتمام جمع آوری نمونه ها وپیگیری بیماران و آنالیز نتایج بدست آورده بروز رسانی در سامانه انجام می شود.
باتوجه به مطالعه پیلوت درروند کار طبق صلاحدید همکار آمار نمونه از 6 نفر به 10 کیس افزایش یافت.
بعلت تکمیل نتایج آماری نهایی وتکمیل پیامدها سامانه آپدیت شد.
بعلت ثبت اولیه درتکمیل نتایج آماری نهایی وتکمیل پیامدها سامانه مطالعه کارآزمایی بالینی واتمام جمع آوری نمونه ها وپیگیری بیماران و آنالیز نتایج بدست آورده بروز رسانی در سامانه انجام می شودآپدیت شد. باتوجه به مطالعه پیلوت درروند کار طبق صلاحدید همکار آمار نمونه از 6 نفر به 10 کیس افزایش یافت.
Secondary outcomes
#1
میکروسکوپ
6 day after stimulation
میکروسکوپ6 day after stimulation
#2
14 and 16 days after transfer
5 weeks after transfer
14 and 16 days5 weeks after transfer
14 و 16 روز
5 هفته بعدازترانسفر
14 و 16 روز5 هفته بعدازترانسفر
bhcg test
tvs sonography
bhcg testtvs sonography
تست bhcg
سونو واژینال
تست bhcgسونو واژینال
#3
empty
clinical pregnancy rate
clinical pregnancy rate
empty
نرخ حاملگی بالینی
نرخ حاملگی بالینی
empty
5 weeks after transfer
5 weeks after transfer
empty
5 هفته بعدازترانسفر
5 هفته بعدازترانسفر
empty
tvs sonography
tvs sonography
empty
سونو واژینال
سونو واژینال
#4
empty
number of embryos transferred
number of embryos transferred
empty
تعداد جنین های منتقل شده
تعداد جنین های منتقل شده
empty
6 day after stimulation
6 day after stimulation
empty
6 روز بعد از تحریک
6 روز بعد از تحریک
empty
microscopic
microscopic
empty
6 day after stimulation
6 day after stimulation
Protocol summary
Study aim
Improving the number and quality of follicles in people with decreased ovarian reserve
Design
In this clinical trial without a control group, without blinding,10 patients with decreased ovarian reserve (based on inclusion and exclusion criteria) are subjected to IVA surgery in one ovary,
Settings and conduct
10 patients suffering from decreased ovarian reserve (based on entry and exit criteria) referred to Tehran Taleghani Hospital's Infertility Center underwent IVA surgery in one ovary and as a clinical trial without control group, without blinding of Fsh /AMH /E2 serum levels. And the number of AFC has been investigated and the patients enter the ovulation stimulation cycle 90 days later.On the day of the operation, patients are subjected to general anesthesia and laparoscopy. A part of the cortex of an ovary is removed from it (size of each biopsy ~5x5x3 mm) and after pathology staining, it is immediately transferred to the adjacent embryology laboratory. The ovary sample is immediately cut into small cubes (1 x 1 x 1 cubic mm) and returned to the ovary. After 3 months, patients enter ovulation stimulation cycles.
Participants/Inclusion and exclusion criteria
The inclusion criteria: < 40 yr old, in POSEIDON group III or IV , AFC<5 ,AMH< 1.2 ng/dl,FSH levels < 10 IU/L with a history of at least one failed stimulation cycle resulting in the inability to retrieve oocyte. Participants with male factor infertility and positive history of hydrosalpinx or anatomical uterine disorders and endocrine disease were excluded from the study
Intervention groups
Patients younger than 40 years old underwent an ovarian reserve decline who underwent IVA and before and after it were evaluated for primary and secondary outcomes.
Main outcome variables
The count of retrieved oocytes,
number of oocytes metaphase II
the number andc quantity of embryos transferred
implantation rate
clinical pregnancy rate.
General information
Reason for update
Due to the completion of the final statistical results and completion of the results, the system was updated.
Acronym
IVA
IRCT registration information
IRCT registration number:IRCT20221016056198N3
Registration date:2023-03-31, 1402/01/11
Registration timing:prospective
Last update:2024-05-26, 1403/03/06
Update count:3
Registration date
2023-03-31, 1402/01/11
Registrant information
Name
Nazanin Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2600
Email address
hajizadeh.nazanin94@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-01, 1402/02/11
Expected recruitment end date
2023-09-20, 1402/06/29
Actual recruitment start date
2023-05-01, 1402/02/11
Actual recruitment end date
2023-09-22, 1402/06/31
Trial completion date
2023-12-21, 1402/09/30
Scientific title
In vitro drug-free activation of the ovarian cortex and its re-transplantation in infertile women with reduced ovarian reserve
Public title
In vitro drug-free activation (IVA) of the ovarian cortex and its re-transplantation in infertile women with reduced ovarian reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age less than 40 years had decreased ovarian reserve based on POSEIDON group 3 and 4 criteria
AMH less than 1 mg/dl
Fsh less than 10
with a history of at least one failed stimulation cycle resulting in the inability to retrieve oocyte
Exclusion criteria:
male factor infertility
positive history of hydrosalpinx
anatomical uterine disorders
endocrine disease
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi avenue, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.897
Health conditions studied
1
Description of health condition studied
Infertile women with reduced ovarian reserve
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
the count of retrieved oocytes
Timepoint
3 months after IVA
Method of measurement
microscopic
2
Description
the count of metaphase II oocytes
Timepoint
3 months after IVA
Method of measurement
microscopic
Secondary outcomes
1
Description
quantity of embryos transferred
Timepoint
6 day after stimulation
Method of measurement
microscopic
2
Description
implantation rate
Timepoint
5 weeks after transfer
Method of measurement
tvs sonography
3
Description
clinical pregnancy rate
Timepoint
5 weeks after transfer
Method of measurement
tvs sonography
4
Description
number of embryos transferred
Timepoint
6 day after stimulation
Method of measurement
microscopic
Intervention groups
1
Description
Intervention group: Infertile women suffering from reduced ovarian reserve are candidates for ovarian cortex activation during laparoscopic surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Nazanin Hajizadeh
Street address
Araabi street, Velanjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Fax
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pooran Saeidi
Street address
Velenjak St
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Fax
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak Street
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak Street, Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arabi Ave, Velenjak Street
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@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