Follicular Activation in Poor Responders (FAPPOR)

César Díaz García

Status: Completed

Conditions: Infertility

Treatments: Procedure: In vitro fragmentation of the ovarian tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT02354963

FAPPOR (2014/0004)

Details and patient eligibility

About

This study aims to assess whether activation of primordial follicles through ovarian cortex fragmentation may increase the number of antral follicles present in the ovary of patients with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and pregnancy rates after IVF.

Hypothesis; Evaluate whether the proposed intervention increases the pool of antral follicles (potentially stimulable ones).

Full description

Controlled, randomized, assessor-blind clinical trial.

Thirty-six patients of La Fe University Hospital (Valencia), previously confirmed as poor responders according to the European Society of Human Reproduction and Embryology (ESHRE) criteria, will be randomized to two treatment arms:

• Arm 1 (control): no intervention.
• Arm 2 (intervention): ovarian cortex extraction by unilateral laparoscopic biopsy and ovarian tissue fragmentation in aliquots of 1 mm2. These fragments will be grafted under the ovarian cortex and meso-ovarium ipsilateraly.

Subsequently the number of antral follicles in both intervention groups will be compared and also will be the number of antral follicles in the native ovary and the grafted one in each of the patients.

Patients will receive a standard IVF treatment for poor responders according to the protocols of the assisted reproduction unit of La Fe University Hospital.

The final aim is to assess the pregnancy rate in both groups, as well as parameters related to the reproduction technique when required.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (must meet one):

• At least two episodes of poor ovarian response (≤ 3 oocytes retrieved with a standard protocol).
• A previous IVF cycle with ≤ 3 oocytes (following a standard stimulation protocol) and presence of an abnormal ovarian reserve test (antral follicle count of ≤ 5 or antimüllerian hormone ≤ 5pm).

Exclusion Criteria (must not meet any):

• Patients under 18 or over 40 years.
• Clinical signs of endometriosis.
• Previous ovarian surgery.
• Genital tract malformations.
• Anovulatory patient (defined by the presence of irregular cycles and serum progesterone ≤ 10 ng / mL on cycle day 21).
• Partner with severe male factor: severe oligoasthenozoospermia, oligoasthenoteratozoospermia and azoospermia.
• All those patients who do not voluntarily give their express written consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Control arm

No Intervention group

Description:

No intervention is performed. Assessment of antral follicle count. IVF treatment.

Experimental arm

Experimental group

Description:

Perform intervention described: Laparoscopy. In vitro fragmentation of the ovarian tissue. Assessment of antral follicle count. IVF treatment.

Treatment:

Procedure: In vitro fragmentation of the ovarian tissue