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
Results First Received: June 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Endometriosis
Infertility
Interventions: Drug: Leuprolide
Procedure: IVF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This prospective, randomized study with control group was carried out at the Department of Obstetrics and Gynecology, Ioannina University School of Medicine (Ioannina, Greece)during a 7-years period (May 2004 to September 2010).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Assessed for eligibility (n= 570) Excluded (n= 390)

  • Not meeting inclusion criteria (n= 102)
  • Declined to participate; underwent expectant management or IUI (n= 253)
  • Other reasons; lost to follow up (n=35)

Reporting Groups
  Description
Endometriosis, GnRH-a Treatment, IVF Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
Endometriosis, IVF Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
Tubal Infertility, IVF Women with tubal infertility underwent an IVF attempt.

Participant Flow:   Overall Study
    Endometriosis, GnRH-a Treatment, IVF     Endometriosis, IVF     Tubal Infertility, IVF  
STARTED     60     60     60  
COMPLETED     53 [1]   55 [2]   60  
NOT COMPLETED     7     5     0  
Adverse Event                 3                 5                 0  
Lost to Follow-up                 4                 0                 0  
[1] lost to follow up:4; OHSS: 2; premature luteinization: 1
[2] OHSS:4; premature luteinization: 1



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Endometriosis, GnRH-a Treatment, IVF Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
Endometriosis, IVF Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
Tubal Infertility, IVF Women with tubal infertility underwent an IVF attempt.
Total Total of all reporting groups

Baseline Measures
    Endometriosis, GnRH-a Treatment, IVF     Endometriosis, IVF     Tubal Infertility, IVF     Total  
Number of Participants  
[units: participants]
  60     60     60     180  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     60     60     60     180  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.8  ± 3.2     31.8  ± 2.1     35.4  ± 1.9     33.6  ± 2.4  
Gender  
[units: participants]
       
Female     60     60     60     180  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
Greece     60     60     60     180  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Pregnancy Rate   [ Time Frame: June 2004-August 2010 ]

2.  Primary:   Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).   [ Time Frame: June 2004-August 2010 ]

3.  Primary:   Fertilization Rate (Percentage of Fertilized Oocytes).   [ Time Frame: June 2004-August 2010 ]

4.  Primary:   Clinical Pregnancy Rate   [ Time Frame: 4 weeks after a positive pregnancy test ]

5.  Secondary:   Follicular Fluid's TNF-a Concentration.   [ Time Frame: June 2004-August 2010 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Apostolos Kaponis, M.D.
Organization: Dept. of Ob/Gyn, Patra University School of Medicine, Greece
phone: +30-2610999569
e-mail: kaponisapostolos@hotmail.com


Publications:

Responsible Party: Apostolos Kaponis, 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