Follicular Activation by Fragmentation of Ovarian Tissue

Diminished Ovarian Reserve Clinical Trial

— FAFOT  

Official title:

Follicular Activation by Fragmentation of Ovarian Tissue

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670407
• Other study ID #: 201810001
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2020
• Source: Podobnik Maternity and Gynecology Hospital
• Contact: Miro S Alebic, MD, PhD
• Phone: +38516398001
• Email: msalebic[@]podobnik.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Diminished Ovarian Reserve

Intervention

Procedure:
• Ovarian tissue fragmentation
Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.

Locations

Country	Name	City	State
Croatia	Podobnik Maternity and Gynecology Hospital	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Podobnik Maternity and Gynecology Hospital

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral follicle count		6 months
Secondary	The number of oocytes retrieved		1 year
Secondary	Clinical pregnancy rate		1 year