Ovarian Fragmentation Study (Crespo Medical Team)

Equipo Juana Crespo

Status: Unknown

Conditions: IVF; Ovarian Failure; Premature Ovarian Failure

Treatments: Procedure: OVARIAN FRAGMENTATION

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04306185

fibrotomia1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

OVARIAN FRAGMENTATION

Experimental group

Description:

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

Treatment:

Procedure: OVARIAN FRAGMENTATION