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Autologous Mitochondrial Transfer in ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study

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ClinicalTrials.gov Identifier: NCT02586298
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Description
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Brief Summary:

The principle objective is to improve embryo quality through autologous micro-injection of mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a complementary ICSI technique in patients with low embryo quality in previous IVF cycles and in those who did not bear children.

This improvement in embryo quality will be determined through on-going pregnancy rate after treatment and/or improvement in embryo quality according to morphological (ASEBIR-"Association for the study of Biology in Reproductive Science), morphokinetic criteria and in Preimplantation Genetic Screening.

Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized in the first part of the study to two treatment groups; standard ICSI procedure without mitochondrial supplementation and ICSI with autologous mitochondrial supplementation. Following an interim analysis of outcomes, an additional 130 patients may be added, for a total of 190 patients.


Condition or disease Intervention/treatment Phase
Infertility Other: Autologous mitochondria with ICSI Other: STANDARD ICSI PROCEDURE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Autologous Mitochondrial Transfer as a Complementary Technique to ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study
Actual Study Start Date : October 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: ICSI with mitochondria
Half of the Metaphase II oocytes retrieved after the controlled ovarian stimulation will be randomized to this group and autologous mitochondria from the patient's ovarian cortex will be introduced into the oocyte during the intracytoplasmic sperm injection in the vitro fertilization treatment.
 Other: Autologous mitochondria with ICSI
Autologous mitochondria during the intracytoplasmic sperm injection (ICSI) process will be added to this randomized group of oocytes.
Active Comparator: Control ICSI without mitochondria
The other half of the metaphase II oocytes retrieved after the controlled ovarian stimulation will be randomized to this group and will not receive autologous mitochondria during the intracytoplasmic sperm injection (ICSI) in the vitro fertilization treatment. Control Group
 Other: STANDARD ICSI PROCEDURE
STANDARD ICSI PROCEDURE


Outcome Measures
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Primary Outcome Measures :
  1. Rate of ongoing pregnancy [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients must have read, understood and signed the ICF.
  • Age ≤ 42 years.
  • Serum AMH ≥ 4 pM/L.
  • Previous IVF cycle with 5 or more metaphase II oocytes after retrieval
  • BMI < 30.
  • Will undergo an IVF cycle with arrays in Preimplantation Genetic Screening.
  • Semen sample with concentrations exceeding 3 million/mL progressive motile sperm.

Present with a history of at least one previous cycle of IVF with embryo transfer and no pregnancy due to low embryo quality. Low embryo quality is understood as > 70% of the embryos obtained being included in the worst prognosis category according to any of the following criteria:

  1. Low or abnormal Fertilization Rate despite semen count > 3 million/mL.

  2. Deficient quality embryos according to morphological criteria established by ASEBIR:

    i. Embryo D2 and D3: classified as Type C or Type D according to ASEBIR criteria.

    ii. Embryo D5 or blastocyst: Inner cell mass absent, with few cells and difficult differentiation, Trophectoderm with very few cells. Type C or D of ASEBIR.

  3. Embryos of deficient quality according to morphokinetic criteria established (28) for EmbryoScope Time-Lapse if this incubator has been used.

    i.Category 4: Embryos of 1 or 2 pronuclei (PN) formed from 1 to 2 cells at 27h, from 2 to 6 cells on D2 and 4 or >8 cells or morula on D3. The embryo can present with asymmetrical and multinucleated blastomeres. Degree of fragmentation < 50%.

    ii. Category 5: Embryo with any number of cells at 27h, on D2 and D3. Asymmetrical, multinucleated blastomeres and any degree of fragmentation. Atretic embryos and those with arrested embryo development belong to this category.

  4. All cases without embryo transfer due to any chromosomal abnormality detected through PGD or PGS techniques.
  5. All cases without transfer due to the presence of embryos that present a blockage of embryo development before D3.

If the morphological quality criteria established under points 2, 3 and 4 give contradictory results, the result obtained through PGD/PGS (point 4) will prevail over the morphokinetic parameters (point 3) and this, in turn, will prevail over the classic morphological criteria (point 2).

Exclusion Criteria:

  • Formal contraindication for ovarian cortex biopsy or follicle puncture.
  • Severe male factor (concentration<3 million/mL of progressive motile sperm).
  • Any characteristic incompatible with carrying out a new IVF cycle at IVI Valencia.
Contacts and Locations
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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): NCT02586298


Locations
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Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
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Study Director: Elena Labarta, MD PhD Gynecologist Specialist TRA, IVI Valencia
Principal Investigator: Antonio Pellicer, MD PhD Gynecologist specialist TRA, President IVI Valencia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT02586298    
Other Study ID Numbers: 1501-VLC-005-AP
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infertility