Protocol summary
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Study aim
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Improving the number and quality of follicles in people with decreased ovarian reserve
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Design
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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,
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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The count of retrieved oocytes,
number of oocytes metaphase II
the number andc quantity of embryos transferred
implantation rate
clinical pregnancy rate.
General information
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Reason for update
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Due to the completion of the final statistical results and completion of the results, the system was updated.
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Acronym
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IVA
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IRCT registration information
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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
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Registration date
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2023-03-31, 1402/01/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-05-01, 1402/02/11
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Expected recruitment end date
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2023-09-20, 1402/06/29
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Actual recruitment start date
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2023-05-01, 1402/02/11
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Actual recruitment end date
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2023-09-22, 1402/06/31
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Trial completion date
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2023-12-21, 1402/09/30
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Scientific title
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In vitro drug-free activation of the ovarian cortex and its re-transplantation in infertile women with reduced ovarian reserve
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Public title
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In vitro drug-free activation (IVA) of the ovarian cortex and its re-transplantation in infertile women with reduced ovarian reserve
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
15
Actual sample size reached:
10
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-05, 1401/12/14
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1401.897
Health conditions studied
1
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Description of health condition studied
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Infertile women with reduced ovarian reserve
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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the count of retrieved oocytes
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Timepoint
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3 months after IVA
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Method of measurement
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microscopic
2
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Description
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the count of metaphase II oocytes
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Timepoint
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3 months after IVA
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Method of measurement
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microscopic
Secondary outcomes
1
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Description
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quantity of embryos transferred
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Timepoint
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6 day after stimulation
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Method of measurement
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microscopic
2
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Description
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implantation rate
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Timepoint
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5 weeks after transfer
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Method of measurement
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tvs sonography
3
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Description
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clinical pregnancy rate
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Timepoint
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5 weeks after transfer
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Method of measurement
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tvs sonography
4
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Description
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number of embryos transferred
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Timepoint
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6 day after stimulation
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Method of measurement
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microscopic
Intervention groups
1
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Description
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Intervention group: Infertile women suffering from reduced ovarian reserve are candidates for ovarian cortex activation during laparoscopic surgery
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available