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:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01385332
First received: May 28, 2010
Last updated: February 13, 2013
Last verified: February 2013

May 28, 2010
February 13, 2013
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. ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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-
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*   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
Female
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01385332
UREP-ONCO-2010
No
Parc de Salut Mar
Parc de Salut Mar
Not Provided
Not Provided
Parc de Salut Mar
February 2013

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