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Status unknownNCT03670407FAFOTUpdated Sep 28, 2020

Follicular Activation by Fragmentation of Ovarian Tissue

An interventional study of Ovarian tissue fragmentation in Diminished Ovarian Reserve, sponsored by Podobnik Maternity and Gynecology Hospital. Status unknown at 1 site in Croatia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-09-28.

Sponsored by Podobnik Maternity and Gynecology Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Diminished Ovarian Reserve

Keywords

  • Premature Ovarian Failure
  • Infertility, Female
  • Ovarian tissue fragmentation
03

In context

Lead sponsor

This is the only study on the registry with Podobnik Maternity and Gynecology Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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 -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureOvarian tissue fragmentation

    Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.

06

What researchers measure

Primary outcomes

  1. Antral follicle count

    Time frame: 6 months

Secondary outcomes

  1. The number of oocytes retrieved

    Time frame: 1 year

  2. Clinical pregnancy rate

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Podobnik Maternity and Gynecology Hospital
    Zagreb, Croatia
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03670407
Lead sponsor
Podobnik Maternity and Gynecology Hospital
Responsible party
Miro Šimun Alebić (Head of human reproduction unit, Podobnik Maternity and Gynecology Hospital) — Principal investigator
First posted
Sep 13, 2018
Start date
Sep 1, 2018
Primary completion
Sep 1, 2021 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
Sep 28, 2020

Study contacts

Miro S Alebić, MD, PhD
Contact
msalebic@podobnik.hr
+38516398001
Milan D Milenkovic, MD, PhD
Contact
milan.d.milenkovic@gmail.com
Miro S Alebić
principal investigator · Podobnik Maternity and Gynecology Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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