GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles.

This study has been completed.
Sponsor:
Collaborators:
University of Patras
Tottori University Hospital
Information provided by (Responsible Party):
Apostolos Kaponis, University of Patras
ClinicalTrials.gov Identifier:
NCT01269125
First received: January 3, 2011
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The investigators attempted to establish a rationale for the Gonadotropin Releasing Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since GnRH-a reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003) and peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid and this action may improve the oocyte quality and the fertility of these women.


Condition Intervention
Endometriosis
Infertility
Drug: Leuprolide
Procedure: IVF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultralong Administration of GnRH-a Before in Vitro Fertilization Improves Fertilization Rate But Not Pregnancy Rate in Women With Endometriosis. A Prospective, Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • Clinical Pregnancy Rate [ Time Frame: June 2004-August 2010 ] [ Designated as safety issue: No ]
    Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.

  • Embryo Quality (the Percentage of Grade 1 Embryos Per Participant). [ Time Frame: June 2004-August 2010 ] [ Designated as safety issue: No ]
    Embryo development was evaluated 2 days after oocyte pick-up. The number of blastomeres and the proportion of embryo volume occupied by fragments were used for the evaluation. Embryos with < 10%, < 10-20%, < 20-30% and >30% fragments were estimated as grade 1,2,3 and 4, respectively.

  • Fertilization Rate (Percentage of Fertilized Oocytes). [ Time Frame: June 2004-August 2010 ] [ Designated as safety issue: No ]
    The fertilization rate was estimated for every woman 24 hours after oocyte retrieval

  • Clinical Pregnancy Rate [ Time Frame: 4 weeks after a positive pregnancy test ] [ Designated as safety issue: No ]
    Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.


Secondary Outcome Measures:
  • Follicular Fluid's TNF-a Concentration. [ Time Frame: June 2004-August 2010 ] [ Designated as safety issue: No ]
    TNF-a was measured in the FF of all women (secondary outcome measures). To prevent any cytokine alterations, only blood-free samples were used.


Enrollment: 180
Study Start Date: May 2004
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endometriosis, leuprolide, IVF
Women with stage II endometriosis received GnRH-a (leuprolide) prior to an IVF attempt.
Drug: Leuprolide
single injection of 3.75 leuprolide every 28 days, 3 dosages
Other Name: Daronda depot 3.75, Abbott, Hellas
Procedure: IVF
Assisted Reproduction Technique.
Active Comparator: Endometriosis, IVF
Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
Drug: Leuprolide
single injection of 3.75 leuprolide every 28 days, 3 dosages
Other Name: Daronda depot 3.75, Abbott, Hellas
Procedure: IVF
Assisted Reproduction Technique.
Active Comparator: Tubal infertility, IVF
Women with tubal infertility underwent an IVF attempt.
Procedure: IVF
Assisted Reproduction Technique.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   29 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertility
  • Mild endometriosis (until stage II)

Exclusion Criteria:

  • ovarian endometrioma > 2 cm
  • FSH > 12 mIU/ml
  • Mail factor infertility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269125

Locations
Greece
Dept. of Obstetrics & Gynecology, University Hospital
Ioannina, Epirus, Greece, 45111
Sponsors and Collaborators
University of Ioannina
University of Patras
Tottori University Hospital
Investigators
Principal Investigator: Apostolos Kaponis, MD Ioannina University School of Medicine
  More Information

Publications:
Responsible Party: Apostolos Kaponis, Lecturer of Ob/Gyn, University of Patras
ClinicalTrials.gov Identifier: NCT01269125     History of Changes
Other Study ID Numbers: 2003/89 PGNI
Study First Received: January 3, 2011
Results First Received: June 29, 2012
Last Updated: July 23, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Ioannina:
cytokines
endometriosis
fertilization rate
follicular fluid
pregnancy rate

Additional relevant MeSH terms:
Endometriosis
Infertility
Genital Diseases, Female
Genital Diseases, Male
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014