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Ovarian Fragmentation Study (Crespo Medical Team)

Ovarian Fragmentation Study (Crespo Medical Team)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04306185
Enrollment
30
Registered
2020-03-12
Start date
2020-05-01
Completion date
2021-03-01
Last updated
2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF, Ovarian Failure, Premature Ovarian Failure

Keywords

ovarian fragmentation, Kawamura, ovarian rejuvenation

Brief summary

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.

Interventions

PROCEDUREOVARIAN FRAGMENTATION

BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS

Sponsors

Equipo Juana Crespo
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)1 yearEmbryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015).

Secondary

MeasureTime frameDescription
- Follicle growth rate before and after ovarian cortex fragmentation.2 months.Number of antral Follicles in IVF treatment before ovarian fragmentation and after IVF following ovarian fragmentation.
- 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

Countries

Spain

Contacts

Primary ContactANDER MORALES VICENTE
andermoralesvicente@gmail.com628802099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026