Follicular Activation by Fragmentation of Ovarian Tissue (FAFOT)

Podobnik Maternity and Gynecology Hospital

Status: Unknown

Conditions: Diminished Ovarian Reserve

Treatments: Procedure: Ovarian tissue fragmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT03670407

201810001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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 -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control group

No Intervention group

Description:

Participants who opt not to go ahead with ovarian fragmentation.

Study group

Experimental group

Description:

Participants who opt for ovarian fragmentation.

Treatment:

Procedure: Ovarian tissue fragmentation