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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

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ClinicalTrials.gov Identifier: NCT01385332
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Miguel Angel Checa, Parc de Salut Mar

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stimulation in the Ovary Procedure: Early luteal phase Procedure: Late follicular phase -COH- Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors
Study Start Date : March 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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.
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.
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.
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01385332


Locations
Spain
Servei de Ginecologia i Obstetricia, Hospital del Mar-Parc Salut Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar

Responsible Party: Miguel Angel Checa, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01385332     History of Changes
Other Study ID Numbers: UREP-ONCO-2010
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Miguel Angel Checa, Parc de Salut Mar:
Metaphase II
Ovarian stimulation
Egg donors

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases