Diminished Ovarian ReserveFAFOTNCT03670407
Follicular Activation by Fragmentation of Ovarian Tissue
A study testing Ovarian tissue fragmentation in people with Diminished Ovarian Reserve, run by Podobnik Maternity and Gynecology Hospital at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- Ovarian tissue fragmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2018to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- 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
- premature ovarian insufficiency according to European Society of Human Reproduction and Embryology (ESHRE) development group, 2015 in patients 18-40 years
- undetectable AMH serum levels and follitropin (FSH) >35 IU/ml in two serum samples separated by at least 4 weeks
Who cannot join
- clinical/ultrasonographical signs of endometriosis
- previous ovarian/pelvic surgery
- previous gonadotoxic treatment
- genito-urinary tract malformations
- extreme male infertility ( <10 000 progressively motile sperms in the semen sample)
- inform consent unsigned -
Trial locations and contacts
1 site in 1 country.
Milan D Milenkovic, MD, PhD contact
Croatia1 site, 1 recruiting
- Recruiting
Podobnik Maternity and Gynecology Hospital
Zagreb
Miro S Alebić, MD,PhD, +38516398001, msalebic@podobnik.hr
Slava Podobnik Šarkanji, prof, MD, PhD, +38516398000, slava.podobnik@podobnik.hr
About this study
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.
- Conditions
- Diminished Ovarian Reserve
- Being tested
- Ovarian tissue fragmentation
- Keywords
- Premature Ovarian Failure, Infertility, Female, Ovarian tissue fragmentation
- Medical subject headings
- Primary Ovarian Insufficiency, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian tissue fragmentationProcedure or surgery
Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants who opt not to go ahead with ovarian fragmentation. |
| Study group | Experimental | Participants who opt for ovarian fragmentation. Receives: Procedure: Ovarian tissue fragmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral follicle count
Measured: 6 months
Secondary outcomes (2)
The number of oocytes retrieved
Measured: 1 year
Clinical pregnancy rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Podobnik Maternity and Gynecology Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miro Šimun Alebić, Podobnik Maternity and Gynecology Hospital
- Investigators
- Miro S Alebić, Principal investigator, Podobnik Maternity and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670407
- Sponsor's protocol ID
- 201810001
- Acronym
- FAFOT
- Status last verified
- Sep 2020
- First submitted
- 12 Sep 2018
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Activation by Fragmentation of Ovarian Tissue
- ClinicalTrials.gov ID
- NCT03670407
- Acronym / sponsor ID
- FAFOT / 201810001
- Conditions
- Diminished Ovarian Reserve
- Keywords
- Premature Ovarian Failure, Infertility, Female, Ovarian tissue fragmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Podobnik Maternity and Gynecology HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants who opt not to go ahead with ovarian fragmentation. |
| Study group | Experimental | Procedure: Ovarian tissue fragmentationParticipants who opt for ovarian fragmentation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
- 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
- premature ovarian insufficiency according to European Society of Human Reproduction and Embryology (ESHRE) development group, 2015 in patients 18-40 years
- undetectable AMH serum levels and follitropin (FSH) >35 IU/ml in two serum samples separated by at least 4 weeks
Key exclusion criteria (6 listed)
- clinical/ultrasonographical signs of endometriosis
- previous ovarian/pelvic surgery
- previous gonadotoxic treatment
- genito-urinary tract malformations
- extreme male infertility ( <10 000 progressively motile sperms in the semen sample)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovarian tissue fragmentationUnilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation. | Procedure or surgery | Study group |
Primary outcome
Antral follicle count
Time frame: 6 months
2 secondary outcomes
The number of oocytes retrieved
Time frame: 1 year
Clinical pregnancy rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan D Milenkovic, MD, PhD contact
Miro S Alebić principal investigator
Podobnik Maternity and Gynecology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovarian tissue fragmentation in people with Diminished Ovarian Reserve, run by Podobnik Maternity and Gynecology Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miro S Alebić, MD, PhD (+38516398001, msalebic@podobnik.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral follicle count (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.