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A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385332
First Posted: June 30, 2011
Last Update Posted: September 20, 2017
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.
Information provided by (Responsible Party):
Miguel Angel Checa, Parc de Salut Mar
May 28, 2010
June 30, 2011
September 20, 2017
March 2010
June 2012   (Final data collection date for primary outcome measure)
Number of eggs [ Time Frame: Participants will be followed after 1-3 hrs of follicular aspiration. ]
The results will be presented in one year, egg recipients will be followed until 12 weeks of pregnancy.
Number of eggs [ Time Frame: 34-36 hrs after the administration of GnRH we'll do the pick up ]
The results will be presented in one year, egg recipients will be followed until 12 weeks of pregnancy.
Complete list of historical versions of study NCT01385332 on ClinicalTrials.gov Archive Site
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A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors
A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors
The purpose of this study is to determine the efficacy and safety of two new patterns of controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study will be performed in egg donors but these new patterns will be implemented in fertility preservation patients.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stimulation in the Ovary
  • Procedure: Early luteal phase
    We will administer in the tenth day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.
  • Procedure: Late follicular phase -COH-
    We will administer in the 20th day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.
  • Active Comparator: Early luteal phase -COH-
    We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the early luteal phase.
    Intervention: Procedure: Early luteal phase
  • Active Comparator: Late folicular phase - COH -
    We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the late follicular phase.
    Intervention: Procedure: Late follicular phase -COH-
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • premenopausal women 18-30 years old, with FSH levels < 10mIU
  • irregular menstrual cycle
  • BMI between 12-28
  • signed inform consent

Exclusion Criteria:

  • Polycystic ovarian syndrome, gonadotropins allergy
Sexes Eligible for Study: Female
18 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01385332
UREP-ONCO-2010
No
Not Provided
Not Provided
Miguel Angel Checa, Parc de Salut Mar
Parc de Salut Mar
Not Provided
Not Provided
Parc de Salut Mar
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP