Follicular Activation in Poor Responders

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental arm

Perform intervention described: Laparoscopy. In vitro fragmentation of the ovarian tissue.

Assessment of antral follicle count. IVF treatment.

Group Type EXPERIMENTAL

In vitro fragmentation of the ovarian tissue

Intervention Type PROCEDURE

Unilateral ovarian cortex extraction, in vitro fragmentation and reimplantation.

Interventions

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In vitro fragmentation of the ovarian tissue

Unilateral ovarian cortex extraction, in vitro fragmentation and reimplantation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No