Follicular Activation by Fragmentation of Ovarian Tissue (FAFOT)

September 25, 2020 updated by: Miro Šimun Alebić, Podobnik Maternity and Gynecology Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • Podobnik Maternity and Gynecology Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Participants who opt not to go ahead with ovarian fragmentation.
Experimental: Study group
Participants who opt for ovarian fragmentation.
Procedure: Ovarian tissue fragmentation
Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antral follicle count
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of oocytes retrieved
Time Frame: 1 year
1 year
Clinical pregnancy rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Podobnik Maternity and Gynecology Hospital

Investigators

  • Principal Investigator: Miro S Alebić, Podobnik Maternity and Gynecology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201810001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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