Follicular Activation by Fragmentation of Ovarian Tissue

Not Applicable

• Conditions: Diminished Ovarian Reserve
• Interventions: Procedure: Ovarian tissue fragmentation

• Registration Number: NCT03670407
• Lead Sponsor: Podobnik Maternity and Gynecology Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-09-28
• Primary Completion: 2021-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Ovarian tissue fragmentation	Participants who opt for ovarian fragmentation.

Primary Outcome Measures

Name	Time	Method
Antral follicle count	6 months

Secondary Outcome Measures

Name	Time	Method
The number of oocytes retrieved	1 year
Clinical pregnancy rate	1 year

Trial Locations

Locations (1)

Podobnik Maternity and Gynecology Hospital; 🇭🇷 Zagreb, Croatia