Follicular Activation by Fragmentation of Ovarian Tissue

NCT ID: NCT03670407

Last Updated: 2020-09-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-09-01

Brief Summary

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The primary objective of this study is to assess the chances of increasing the number of antral follicles in ovarian tissue of patients with diminished ovarian reserve by activation of primordial follicles through ovarian cortex fragmentation. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.

Detailed Description

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Conditions

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Diminished Ovarian Reserve

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Participants who opt not to go ahead with ovarian fragmentation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group

Participants who opt for ovarian fragmentation.

Group Type EXPERIMENTAL

Ovarian tissue fragmentation

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. previous ≥ 2 poor ovarian responds (≤ 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
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

1. clinical/ultrasonographical signs of endometriosis
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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Podobnik Maternity and Gynecology Hospital

OTHER

Sponsor Role lead

Responsible Party

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Miro Šimun Alebić

Head of human reproduction unit

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Miro S Alebić, MD, PhD

Role: CONTACT

+38516398001

Milan D Milenkovic, MD, PhD

Role: CONTACT

Facility Contacts

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Miro S Alebić, MD,PhD

Role: primary

+38516398001

Slava Podobnik Šarkanji, prof, MD, PhD

Role: backup

+38516398000

Other Identifiers

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201810001

Identifier Type: -

Identifier Source: org_study_id

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