Follicular Activation by Fragmentation of Ovarian Tissue
NCT ID: NCT03670407
Last Updated: 2020-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-09-01
2022-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Participants who opt not to go ahead with ovarian fragmentation.
No interventions assigned to this group
Study group
Participants who opt for ovarian fragmentation.
Ovarian tissue fragmentation
Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.
Interventions
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Ovarian tissue fragmentation
Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.
Eligibility Criteria
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Inclusion Criteria
2. previous cycle with ≤ 3 retrieved oocytes) in an antagonist cycle with a minimum of 225 IU gonadotropins a day or corifollitropin 150 mcg) in patients \>35 i \<40 years with antral follicle count (AFC) ≤ 5 i/ili antiM¸ulelrian hormone (AMH) ≤ 6.5pmol/L
3. premature ovarian insufficiency according to European Society of Human Reproduction and Embryology (ESHRE) development group, 2015 in patients 18-40 years
4. undetectable AMH serum levels and follitropin (FSH) \>35 IU/ml in two serum samples separated by at least 4 weeks
Exclusion Criteria
2. previous ovarian/pelvic surgery
3. previous gonadotoxic treatment
4. genito-urinary tract malformations
5. extreme male infertility ( \<10 000 progressively motile sperms in the semen sample)
6. inform consent unsigned -
18 Years
40 Years
FEMALE
No
Sponsors
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Podobnik Maternity and Gynecology Hospital
OTHER
Responsible Party
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Miro Šimun Alebić
Head of human reproduction unit
Principal Investigators
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Miro S Alebić
Role: PRINCIPAL_INVESTIGATOR
Podobnik Maternity and Gynecology Hospital
Locations
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Podobnik Maternity and Gynecology Hospital
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201810001
Identifier Type: -
Identifier Source: org_study_id
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