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

Primary Purpose

INFERTILITY, Fertility Preservation, Ovulation Induction

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
gonadotropins plus GnRH antagonists
ganirelix
Sponsored by
Institut Universitari Dexeus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for INFERTILITY focused on measuring Ovarian stimulation, Luteal phase, Egg donors, Fertility preservation

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lutheal phase ovarian stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

Number of Mature oocytes

Full Information

First Posted
July 18, 2012
Last Updated
October 24, 2014
Sponsor
Institut Universitari Dexeus
Collaborators
FUNDACION DEXEUS SALUT DE LA DONA, Ayudas Merck Serono de Investigación 2012
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1. Study Identification

Unique Protocol Identification Number
NCT01645241
Brief Title
Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation
Official Title
Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Universitari Dexeus
Collaborators
FUNDACION DEXEUS SALUT DE LA DONA, Ayudas Merck Serono de Investigación 2012

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
INFERTILITY, Fertility Preservation, Ovulation Induction, Vitrification, Oocyte Donation
Keywords
Ovarian stimulation, Luteal phase, Egg donors, Fertility preservation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lutheal phase ovarian stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gonadotropins plus GnRH antagonists
Other Intervention Name(s)
Ovarian stimulation
Intervention Type
Drug
Intervention Name(s)
ganirelix
Other Intervention Name(s)
the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix
Primary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
six weeks after transfer procedure
Secondary Outcome Measure Information:
Title
Number of Mature oocytes
Time Frame
Day of oocyte retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisca Martínez, PhD
Organizational Affiliation
Fundación Dexeus Salut de la Dona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08037
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21292255
Citation
Sonmezer M, Turkcuoglu I, Coskun U, Oktay K. Random-start controlled ovarian hyperstimulation for emergency fertility preservation in letrozole cycles. Fertil Steril. 2011 May;95(6):2125.e9-11. doi: 10.1016/j.fertnstert.2011.01.030. Epub 2011 Feb 3.
Results Reference
background
PubMed Identifier
18930226
Citation
von Wolff M, Thaler CJ, Frambach T, Zeeb C, Lawrenz B, Popovici RM, Strowitzki T. Ovarian stimulation to cryopreserve fertilized oocytes in cancer patients can be started in the luteal phase. Fertil Steril. 2009 Oct;92(4):1360-1365. doi: 10.1016/j.fertnstert.2008.08.011. Epub 2008 Oct 18.
Results Reference
background
PubMed Identifier
25154677
Citation
Martinez F, Clua E, Devesa M, Rodriguez I, Arroyo G, Gonzalez C, Sole M, Tur R, Coroleu B, Barri PN. Comparison of starting ovarian stimulation on day 2 versus day 15 of the menstrual cycle in the same oocyte donor and pregnancy rates among the corresponding recipients of vitrified oocytes. Fertil Steril. 2014 Nov;102(5):1307-11. doi: 10.1016/j.fertnstert.2014.07.741. Epub 2014 Aug 22.
Results Reference
derived
Links:
URL
http://www.dexeus.com
Description
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Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

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