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Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation
This study has been completed.
Sponsor:
Institut Universitari Dexeus
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
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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: | 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:
Further study details as provided by Institut Universitari Dexeus:
Primary Outcome Measures:
- Pregnancy rate [ Time Frame: six weeks after transfer procedure ]
Secondary Outcome Measures:
- Number of Mature oocytes [ Time Frame: Day of oocyte retrieval ]
| 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 (Adult) |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01645241
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:
Publications:
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 |
Keywords provided by Institut Universitari Dexeus:
|
Ovarian stimulation Luteal phase Egg donors Fertility preservation |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Ganirelix |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 21, 2017