1. Home
  2. Approved trials
  3. » فارسی

In vitro drug-free activation of the ovarian cortex and its re-transplantation in infertile women with reduced ovarian reserve

View the latest revision

History
# Registration date Revision Id
4 2024-05-23, 1403/03/03 302984
3 2024-05-11, 1403/02/22 302054
2 2024-04-15, 1403/01/27 300212
1 2023-03-31, 1402/01/11 260172
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    In this research, a clinical trial without a control group, without blinding, 6 patients with decreased ovarian reserve (based on inclusion and exclusion criteria) are subjected to IVA surgery in one ovary, and the serum level of 2 Fsh / AMH /E2 and the number of AFC are investigated.
    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,
    در این تحقیق کارآزمایی بالینی بدون گروه کنترل، بدون کورسازی 6 بیمار مبتلا به کاهش ذخیره تخمدان (بر اساس معیارهای ورود و خروج) تحت جراحی IVA در یک تخمدان قرار می گیرند و سطح سرمی2 Fsh /AMH /E و تعداد AFCمورد بررسی قرار می گیرند.
    در این کارآزمایی بالینی بدون گروه کنترل، بدون کورسازی 10 بیمار مبتلا به کاهش ذخیره تخمدان (بر اساس معیارهای ورود و خروج) تحت جراحی IVA در یک تخمدان قرار می گیرند
    In this research, 6 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 75 days later. Written consent is obtained from all patients. 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 5 weeks, patients enter ovulation stimulation cycles.
    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.
    در این تحقیق 6 بیمار مبتلا به کاهش ذخیره تخمدان (بر اساس معیارهای ورود و خروج) مراجعه کننده به مرکز ناباروری بیمارستان طالقانی تهران در یک تخمدان و به صورت کارآزمایی بالینی بدون کور کردن سطوح سرمی Fsh /AMH / E2 تحت عمل جراحی IVA قرار گرفتند و تعداد AFC بررسی شده و بیماران 75 روز بعد وارد چرخه تحریک تخمک گذاری می شوند. رضایت کتبی از همه بیماران گرفته می شود. در روز عمل، بیماران تحت بیهوشی عمومی و لاپاراسکوپی قرار می گیرند. قسمتی از قشر تخمدان از آن جدا می شود (اندازه هر بیوپسی ~5x5x3 میلی متر) و پس از رنگ آمیزی پاتولوژی بلافاصله به آزمایشگاه جنین شناسی مجاور منتقل می شود. نمونه تخمدان بلافاصله به مکعب های کوچک (1×1×1 میلی متر مکعب) بریده شده و به تخمدان برگردانده می شود. پس از 5 هفته، بیماران وارد چرخه های تحریک تخمک گذاری می شوند.
    10 بیمار مبتلا به کاهش ذخیره تخمدان (بر اساس معیارهای ورود و خروج) مراجعه کننده به مرکز ناباروری بیمارستان طالقانی تهران در یک تخمدان و به صورت کارآزمایی بالینی بدون کور کردن سطوح سرمی Fsh /AMH / E2 تحت عمل جراحی IVA قرار گرفتند و تعداد AFC بررسی شده و بیماران 90 روز بعد وارد چرخه تحریک تخمک گذاری می شوند. در روز عمل، بیماران تحت بیهوشی عمومی و لاپاراسکوپی قرار می گیرند. قسمتی از قشر تخمدان از آن جدا می شود (اندازه هر بیوپسی ~5x5x3 میلی متر) و پس از رنگ آمیزی پاتولوژی بلافاصله به آزمایشگاه جنین شناسی مجاور منتقل می شود. نمونه تخمدان بلافاصله به مکعب های کوچک (1×1×1 میلی متر مکعب) بریده شده و به تخمدان برگردانده می شود. پس از3 ماه، بیماران وارد چرخه های تحریک تخمک گذاری می شوند.
    Patients <40 years had decreased ovarian reserve based on POSEIDON group 3 and 4 criteria and AMH less than 1 mg/dl and their serum FSH less than 10 ABUD were included in conditions. Exclusion criteria: People <18 years and more than 40 years old And people with normal ovarian reserves and Fsh > 18 are 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.
    بیماران با سن کمتر از 40 سال کاهش ذخیره تخمدانی بر اساس معیارهای POSEIDON گروه 3 و 4 و AMH کمتر از 1 mg/dl داشتند و fsh سرمی انها کمتر از 10 بود، وارد مطالعه می شوند. شرایط عدم ورود: افراد با سن کمتر از 18 سال و بیشتر از 40 سال و افراد با ذخیره تخمدانی نرمال و Fsh بیشتر از 18 از مطالعه خارج می شوند
    معیارهای ورود شامل :کمتر از 40 سال، POSEIDON گروه III یا IV ، با AFC <5 و AMH زیر 1.2 نانوگرم در دسی لیتر، FSH < 10 IU/L با سابقه حداقل یک چرخه تحریک ناموفق که منجر به ناتوانی در بازیابی تخمک می شود. شرکت کنندگان با ناباروری عامل مردانه و سابقه مثبت هیدروسالپینکس یا اختلالات آناتومیک رحم و بیماری غدد درون ریز از مطالعه حذف شدند.
    Patients < 40 years had decreased ovarian reserve included in the study, and ovarian reserve and response to ovulation stimulation cycle are examined.
    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.
    بیماران با سن کمتراز 40 سال کاهش ذخیره تخمدانی و از نظر رزرو تخمدانی و پاسخ به سیکل تحریک تخمک گذاری مورد بررسی قرار می گیرند.
    بیماران با سن کمتراز 40 سال کاهش ذخیره تخمدانی که تحت IVA قرار می گیرند و قبل وبعد از آن مورد بررسی از نظر پیامدهای اولیه وثانویه قرارمی گیرند.
    Serum FSH level AMH serum level Number of AFC
    The count of retrieved oocytes, number of oocytes metaphase II, the quantity of embryos transferred, implantation rate clinical pregnancy rate.
    سطح سرمی FSH سطح سرمی AMH تعداد AFC
    تعداد تخمک‌های بازیابی شده، تعداد تخمک‌هایی متافاز 2 ، تعداد جنین‌های منتقل‌شده، میزان لانه‌گزینی نرخ حاملگی بالینی

  • General information

    empty
    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.
    empty
    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.
    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
    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
    بیماران با سن کمتراز 40 سال کاهش ذخیره تخمدانی بر اساس معیارهای POSEIDON گروه 3و4
    AMHکمتراز 1 mg/dl
    Fsh سرمی کمتر از 10
    بیماران با سن کمتراز 40 سال کاهش ذخیره تخمدانی بر اساس معیارهای POSEIDON گروه 3و4
    AMHکمتراز 1 mg/dl
    Fsh سرمی کمتر از 10
    با سابقه حداقل یک چرخه تحریک ناموفق که منجر به ناتوانی در بازیابی تخمک شده است
    Patients over 40 years old and under 18 years old
    AMH greater than 1 mg/dl
    FSH greater than 10
    male factor infertility
    positive history of hydrosalpinx
    anatomical uterine disorders
    endocrine disease
    بیماران با سن بیشتر از 40 سال و کمتر از 18 سال
    AMH بیشتر از 1 mg/dl
    FSH بیشتر از 10
    ناباروری با فاکتور مردانه
    سابقه هیدروسالپنکس
    اختلالات ساختاری رحم
    بیماری اندوکرین

  • Primary outcomes

    #1
    Serum FSH level
    the count of retrieved oocytes
    سطح سرمی FSH
    تعداد اووسیت های گرفته شده
    First and 75 days later
    3 months after IVA
    ابتدا و 75 روز بعد
    3ماه بعد از IVA
    Blood serum level
    microscopic
    سطح سرمی خونی
    میکروسکوپ
    #2
    Serum AMH level
    the count of metaphase II oocytes
    سطح سرمی AMH
    تعداد اووسیت های متافاز 2
    First and 75 days later
    3 months after IVA
    ابتدا و 75 روز بعد
    3ماه بعد از IVA
    Blood serum level
    microscopic
    سطح سرمی خونی
    3ماه بعد از IVA
    #3
    Number of antral follicles
    empty
    تعداد فولیکول های آنترال
    empty
    First and 75 days later
    empty
    ابتدا و 75 روز بعد
    empty
    Transvaginal Sonography
    empty
    سونوگرافی واژینال
    empty

  • Secondary outcomes

    #1
    The number of mature follicles in response to ovulation stimulation
    quantity of embryos transferred
    تعداد فولیکول بالغ درپاسخ به تحریک تخمک گذاری
    کیفیت جنین های منتقل شده
    Start of stimulation cycle and puncture day
    6 day after stimulation
    شروع سیکل تحریک و روز پانکچر
    6 روز بعد از تحریک
    Vaginal Sonography
    microscopic
    سونوگرافی واژینال
    میکروسکوپ
    #2
    empty
    implantation rate
    empty
    نرخ لانه گزینی
    empty
    14 and 16 days after transfer
    empty
    14 و 16 روز
    empty
    bhcg test
    empty
    تست bhcg

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Vice President of Research and Technology
    Full name of responsible person - Persian: Vice President of Research and Technologyمعاون تحقیقات وفناوری
    Street address - English: Velenjak St
    Street address - Persian: خیابان ولنجک
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 2243 2600
    Fax: +98 21 2243 2600
    Email: Hajizadeh.nazanin94@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Pooran Saeidi
    Full name of responsible person - Persian: پوران سعیدی
    Street address - English: Velenjak St
    Street address - Persian: خیابان ولنجک
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 2243 2600
    Fax: +98 21 2243 2600
    Email: Hajizadeh.nazanin94@yahoo.com
    Web page address:

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 quantity of embryos transferred, implantation rate clinical pregnancy rate.

General information

Reason for update
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.
Acronym
IVA
IRCT registration information
IRCT registration number: IRCT20221016056198N3
Registration date: 2023-03-31, 1402/01/11
Registration timing: prospective

Last update: 2024-04-29, 1403/02/10
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
2023-04-09, 1402/01/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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: 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
14 and 16 days after transfer
Method of measurement
bhcg test

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
Loading...