Ovarian Fragmentation Study (Crespo Medical Team)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-03-01

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.

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Detailed Description

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Conditions

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Ovarian Failure Premature Ovarian Failure IVF

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OVARIAN FRAGMENTATION

Ovarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve).

Group Type EXPERIMENTAL

OVARIAN FRAGMENTATION

Intervention Type PROCEDURE

BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS

Interventions

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OVARIAN FRAGMENTATION

BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS

Intervention Type PROCEDURE

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No