Ovarian Fragmentation Study (Crespo Medical Team)

Equipo Juana Crespo30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Failure Premature Ovarian Failure IVF

Interventions

OVARIAN FRAGMENTATIONPROCEDURE

BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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: 1. Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma). 2. Age over 45 years (EMC) 3. Previous ovarian/pelvic surgery. Unilateral oophorectomy. 4. Body Mass Index \> 30 5. Previous gonadotoxic treatment. 6. Genito-urinary tract malformations. 7. Inform consent unsigned.

Locations (1)

Ander Morales Vicente

Valencia, Spain

Outcomes

Primary Outcomes

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).

Time frame: 1 year

Secondary Outcomes

- 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.

Time frame: 2 months.

- Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.

Time frame: 2 months

- AntiMullerian hormone (AMH) serum levels before and two months after the procedure.

Time frame: 2 months.

- Number of embryos before and after ovarian cortex fragmentation.

Time frame: 2 months

- Clinical pregnancy rate following ovarian cortex fragmentation.

Time frame: 1 year

Central Contacts

ANDER MORALES VICENTE

CONTACT

628802099 andermoralesvicente@gmail.com

Data from ClinicalTrials.gov

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