Ovarian Fragmentation Study (Crespo Medical Team)

Study Overview
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Brief Summary
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This is a study designed to validate Kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. Our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.

Official Title
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Ovarian Fragmentation Study (Crespo Medical Team)

Conditions
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Ovarian Failure, Premature Ovarian Failure, IVF

Intervention / Treatment
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* Procedure: OVARIAN FRAGMENTATION


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominal surgery need for fertility cause. Bad embryo quality (>2 cycles with < 1 embryo A-B quality. With: A. Poor ovarian responders (previous ≤ 3 retrieved metaphase II oocytes) in a conventional cycle. B. Decreased ovarian reserve (antral follicle count (AFC) ≤ 5 or antiMullerian hormone (AMH) ≤ 0.5 ng/mL). C.Premature ovarian insufficiency according to: Patients < 40 years old. At least 1 year of amenorrhea. Follitropin serum levels (FSH) >35 IU/ml in two serum samples separated by at least 1 month. Estradiol serum levels (E2) < 20 pg/mL. Exclusion Criteria: Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma). Age over 45 years (EMC) Previous ovarian/pelvic surgery. Unilateral oophorectomy. Body Mass Index > 30 Previous gonadotoxic treatment. Genito-urinary tract malformations. Inform consent unsigned.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OVARIAN FRAGMENTATION<br>Ovarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve). | Procedure: OVARIAN FRAGMENTATION<br>* BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015) | Embryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Follicle growth rate before and after ovarian cortex fragmentation. | Number of antral Follicles in IVF treatment before ovarian fragmentation and after IVF following ovarian fragmentation. | 2 months. | 
| - Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation. |  | 2 months | 
| - AntiMullerian hormone (AMH) serum levels before and two months after the procedure. |  | 2 months. | 
| - Number of embryos before and after ovarian cortex fragmentation. |  | 2 months | 
| - Clinical pregnancy rate following ovarian cortex fragmentation. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian fragmentation, Kawamura, ovarian rejuvenation