Follicular Activation by Fragmentation of Ovarian Tissue

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03670407

Acronym

FAFOT

Enrollment

Registered

2018-09-13

Start date

2018-09-01

Completion date

2022-09-01

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diminished Ovarian Reserve

Keywords

Premature Ovarian Failure, Infertility, Female, Ovarian tissue fragmentation

Brief summary

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.

Interventions

PROCEDUREOvarian tissue fragmentation

Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame
Antral follicle count	6 months

Secondary

Measure	Time frame
The number of oocytes retrieved	1 year
Clinical pregnancy rate	1 year

Countries

Croatia

Contacts

Primary ContactMiro S Alebić, MD, PhD

msalebic@podobnik.hr+38516398001

Backup ContactMilan D Milenkovic, MD, PhD

milan.d.milenkovic@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026