Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follicular Activation in Poor Responders (FAPPOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354963
Recruitment Status : Unknown
Verified September 2016 by Instituto de Investigacion Sanitaria La Fe.
Recruitment status was:  Recruiting
First Posted : February 3, 2015
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Infertility Procedure: In vitro fragmentation of the ovarian tissue Not Applicable

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Follicle Activation in Patients With Poor Ovarian Response Through Fragmentation of the Ovarian Tissue.
Study Start Date : November 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Control arm
No intervention is performed. Assessment of antral follicle count. IVF treatment.
Experimental: Experimental arm

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

Assessment of antral follicle count. IVF treatment.

 Procedure: In vitro fragmentation of the ovarian tissue
Unilateral ovarian cortex extraction, in vitro fragmentation and reimplantation.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Antral follicle count [ Time Frame: Up to 6 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354963


Contacts
Layout table for location contacts
Contact: Cesar Diaz-Garcia, MD cesar.diaz@uv.es

Locations
Layout table for location information
Spain
La Fe University Hospital Recruiting
Valencia, Spain
Contact: César Díaz García    +34618830870    cesar.diaz@uv.es   
Sub-Investigator: Carlos Simón Vallés         
Sub-Investigator: Antonio Pellicer Martínez         
Sub-Investigator: Sonia Herraiz Raya         
Sub-Investigator: Loida Pamplona Bueno         
Sub-Investigator: Natalia Fischer Suárez         
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
Layout table for investigator information
Principal Investigator: Cesar Diaz-Garcia, MD La Fe University Hospital. University of Valencia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT02354963    
Other Study ID Numbers: 2014/0004
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: September 2016
Keywords provided by Instituto de Investigacion Sanitaria La Fe:
Poor ovarian response
Salvador/Warts/Hippo pathway
Follicular activation
Poor ovarian reserve
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility