Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women (IVM)
Primary Purpose
Female Infertility
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
IN VITRO MATURATION AND OOCYTE ACTIVATION
Sponsored by
About this trial
This is an interventional other trial for Female Infertility focused on measuring OOCYTE ACTIVATION, IN VITRO MATURATION, OOCYTE RETRIEVAL, DONNOR, hMG-HP
Eligibility Criteria
Inclusion Criteria:
- Woman aged 18-35 years who have belonged to the egg donation program.
- Donors who agree to participate in the pre-trial report and sign informed consent.
- Good previous documented response to ovarian stimulation (at least 10 oocytes total and/or 8 MII).
- Donors with at least one previous cycle of donation, in which all the oocytes obtained were fertilized in fresh
- Patients who come to their last cycle of donation allowed by law
- No personal or family medical disorders history.
- Body mass index between 18-28 kg/m2
- Normal uterus and ovaries, without organic pathology
- Non-polycystic-looking ovaries
- Antral follicle Count (AFC) > 12 from both ovaries on day 2-3 of the menstrual cycle.
- Normal Karyotype
- Negative values of infectious diseases (hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis)
- Analytical with CBC, hemostasis and biochemistry with parameters within normality
Exclusion Criteria:
- Any systemic or metabolic disorder that counterindicates the use of gonadotrophins.
- Any medical condition involving non-inclusion in the oocyte donation program
- Who are taking hormonal contraceptives in the last 3 months
- Severe male Factor (Semen < 3 million)
Sites / Locations
- Ivi Valencia
Outcomes
Primary Outcome Measures
rate of obtaining potentially competent oocytes
Number of potentially competent oocytes (after in vitro maturation and oocyte activation).
Secondary Outcome Measures
Oocyte retrieval rate
Number of Oocyte retrieved per punctured follicle.
Artificial oocyte activation rate.
Number of activated oocyte obtained.
In vitro nuclear maturation rate.
Number of oocyted with matured nucleous.
Fertilization rate
Number of Fertilized oocytes obtained in a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.
Mature oocytes rate
Number of Mature oocytes obtained in of a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.
Full Information
NCT ID
NCT03998553
First Posted
June 3, 2019
Last Updated
January 27, 2020
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
1. Study Identification
Unique Protocol Identification Number
NCT03998553
Brief Title
Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
Acronym
IVM
Official Title
Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In vitro maturation (IVM) is a technique for obtaining potentially fertilizable oocytes from immature oocytes. An oocyte must be mature both nuclearly and cytoplasmically in order to be competent in the reproductive process. Nuclear maturation involves an oocyte in metaphase II stage and is easily evaluated for its morphology. However, cytoplasmic maturation can only be evaluated by in vitro fertilization of that oocyte A mature nuclear and cytoplasmic oocyte is one capable of producing a viable embryo. This study aims to fine-tune the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.
The aim of this study is to evaluate the response to the strategy stimulation with highly purified human menopausal gonadotropin (hMG-HP) administered for three days, in association with a standard methodology of in vitro oocyte maturation (IVM), to be performed on oocyte donors.
The correct functioning of this IVM technique would mean a reduction in the costs of ovarian stimulation treatments, as lower doses and shorter stimulation times are required, which implies lower risks for women derived from the medication and less stress for them.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
Keywords
OOCYTE ACTIVATION, IN VITRO MATURATION, OOCYTE RETRIEVAL, DONNOR, hMG-HP
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective and unicentric cohort pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
IN VITRO MATURATION AND OOCYTE ACTIVATION
Intervention Description
This study aims to fine-tune the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.
Primary Outcome Measure Information:
Title
rate of obtaining potentially competent oocytes
Description
Number of potentially competent oocytes (after in vitro maturation and oocyte activation).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Oocyte retrieval rate
Description
Number of Oocyte retrieved per punctured follicle.
Time Frame
6 months
Title
Artificial oocyte activation rate.
Description
Number of activated oocyte obtained.
Time Frame
6 months
Title
In vitro nuclear maturation rate.
Description
Number of oocyted with matured nucleous.
Time Frame
6 months
Title
Fertilization rate
Description
Number of Fertilized oocytes obtained in a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.
Time Frame
6 months
Title
Mature oocytes rate
Description
Number of Mature oocytes obtained in of a previous cycle of fresh donation of donor versus the obtained on in vitro maturation cycle.
Time Frame
6 months
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:
Woman aged 18-35 years who have belonged to the egg donation program.
Donors who agree to participate in the pre-trial report and sign informed consent.
Good previous documented response to ovarian stimulation (at least 10 oocytes total and/or 8 MII).
Donors with at least one previous cycle of donation, in which all the oocytes obtained were fertilized in fresh
Patients who come to their last cycle of donation allowed by law
No personal or family medical disorders history.
Body mass index between 18-28 kg/m2
Normal uterus and ovaries, without organic pathology
Non-polycystic-looking ovaries
Antral follicle Count (AFC) > 12 from both ovaries on day 2-3 of the menstrual cycle.
Normal Karyotype
Negative values of infectious diseases (hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis)
Analytical with CBC, hemostasis and biochemistry with parameters within normality
Exclusion Criteria:
Any systemic or metabolic disorder that counterindicates the use of gonadotrophins.
Any medical condition involving non-inclusion in the oocyte donation program
Who are taking hormonal contraceptives in the last 3 months
Severe male Factor (Semen < 3 million)
Facility Information:
Facility Name
Ivi Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
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