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Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

This study has been completed.
Sponsor:
Collaborators:
FUNDACION DEXEUS SALUT DE LA DONA
Ayudas Merck Serono de Investigación 2012
Information provided by:
Institut Universitari Dexeus
ClinicalTrials.gov Identifier:
NCT01645241
First received: July 18, 2012
Last updated: October 24, 2014
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . This study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients


Condition Intervention
INFERTILITY
Fertility Preservation
Ovulation Induction
Vitrification
Oocyte Donation
 Drug: gonadotropins plus GnRH antagonists
Drug: ganirelix

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Universitari Dexeus:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: six weeks after transfer procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Mature oocytes [ Time Frame: Day of oocyte retrieval ] [ Designated as safety issue: No ]
Enrollment: 15
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lutheal phase ovarian stimulation
Early luteal phase Controlled ovarian hyperstimulation: we will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix to induce luteolysis and FSHr (dose according to BMI and AFC )IU/day for controlled ovarian hyperstimulation until achieving criteria for hCG , to induce final oocyte maturation. Mature oocytes will be vitrified. After warming, oocytes will be inseminated by ICSI with the recipients partners semen sample . Recipient endometrium will be primed with estrogen and progesterone , and embryo transfer will be performed on the 3rd day 3 of embryo cleavage.
 Drug: gonadotropins plus GnRH antagonists
Other Name: Ovarian stimulation
Drug: ganirelix
Other Name: the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix

  Eligibility
Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • premenopausal women, 18-35 years old, FSH levels < 10 mIU/ml; AFC> 10
  • regular cycles
  • BMI < 28
  • signed informed consent

Recipients:

  • Infertile women eligible for oocytes donation
  • BMI < 35
  • Signed informed consent form

Exclusion Criteria:

-Polycystic ovarian syndrome, gonadotropins allergy

Recipients:

  • Women eligible for oocytes donation
  • BMI >35
  • Uncontrolled Endocrine Pathology
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645241

Locations
Spain
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, Spain, 08037
Sponsors and Collaborators
Institut Universitari Dexeus
FUNDACION DEXEUS SALUT DE LA DONA
Ayudas Merck Serono de Investigación 2012
Investigators
Principal Investigator: Francisca Martínez, PhD Fundación Dexeus Salut de la Dona
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01645241     History of Changes
Other Study ID Numbers: DEX005
Study First Received: July 18, 2012
Last Updated: October 24, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Institut Universitari Dexeus:
Ovarian stimulation
Luteal phase
Egg donors
Fertility preservation

Additional relevant MeSH terms:
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015