Follicular Activation in Poor Responders

César Díaz García34 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infertility

Interventions

In vitro fragmentation of the ovarian tissuePROCEDURE

Unilateral ovarian cortex extraction, in vitro fragmentation and reimplantation.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

La Fe University Hospital

Valencia, Spain

Outcomes

Primary Outcomes

Number of Metaphase II (MII)

Number of mature MII oocytes retrieved in the IVF cycles after triggering.

Time frame: 36 hours after triggering

Secondary Outcomes

Total Antral Follicle Count (AFC) - Initial Measure

AFC assessment was done on day 2-5 of the menstrual cycle. Ultrasound scan was performed using a GE iVoluson (General Electric, Spain) equipped with a 3D vaginal probe (6.5-9MHz). A bilateral two-dimensional scan was performed and the mean of the two largest diameters of each intra-ovarian avascular anechoic image was recorded. Antral follicles with a mean diameter from 2 to 10 mm were counted to establish AFC. Initial data refers to the measure taken before treatment.

Time frame: Baseline, day 2-5 of the menstrual cycle prior to treatment

Total Antral Follicle Count (AFC) - Final

AFC assessment was done on day 2-5 of the menstrual cycle and was followed for 6-month. To determine AFC, ultrasound scan was performed using a GE iVoluson (General Electric, Spain) equipped with a 3D vaginal probe (6.5-9MHz). A bilateral two-dimensional scan was performed and the mean of the two largest diameters of each intra-ovarian avascular anechoic image was recorded. Antral follicles with a mean diameter from 2 to 10 mm were counted to establish AFC. Final measure refers to the AFC count after ovarian fragmentation treatment.

Time frame: Day 2-5 of the menstrual cycle 6 months after treatment

Initial Antimüllerian Hormone (AMH) Levels

AMH levels were determined on day 2-5 of the menstrual cycle to establish the initial baseline levels for each patient. A microparticle immunoassay kit integrated in the ABBOTT AxSYM® Plus system and software 5.20 (Abbott Laboratories, Abbot Park, IL, USA) was used to determine AMH levels prior treatment.

Time frame: Baseline, day 2-5 of the menstrual cycle prior to treatment

Final AMH Levels

Data from ClinicalTrials.gov

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