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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

Tracking Information
First Submitted Date  ICMJE October 21, 2015
First Posted Date  ICMJE October 26, 2015
Last Update Posted Date August 23, 2017
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
Rate of ongoing pregnancy [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Mitochondrial Transfer in ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study
Official Title  ICMJE Autologous Mitochondrial Transfer as a Complementary Technique to ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Other: Autologous mitochondria with ICSI
    Autologous mitochondria during the intracytoplasmic sperm injection (ICSI) process will be added to this randomized group of oocytes.
  • Other: STANDARD ICSI PROCEDURE
    STANDARD ICSI PROCEDURE
Study Arms  ICMJE
  • 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.
    Intervention: Other: Autologous mitochondria with ICSI
  • 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
    Intervention: Other: STANDARD ICSI PROCEDURE
Publications * Labarta E, de Los Santos MJ, Herraiz S, Escribá MJ, Marzal A, Buigues A, Pellicer A. Autologous mitochondrial transfer as a complementary technique to intracytoplasmic sperm injection to improve embryo quality in patients undergoing in vitro fertilization-a randomized pilot study. Fertil Steril. 2019 Jan;111(1):86-96. doi: 10.1016/j.fertnstert.2018.09.023. Epub 2018 Nov 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2017)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2015)
30
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02586298
Other Study ID Numbers  ICMJE 1501-VLC-005-AP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Instituto Valenciano de Infertilidad, IVI VALENCIA
Study Sponsor  ICMJE Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elena Labarta, MD PhD Gynecologist Specialist TRA, IVI Valencia
Principal Investigator: Antonio Pellicer, MD PhD Gynecologist specialist TRA, President IVI Valencia
PRS Account Instituto Valenciano de Infertilidad, IVI VALENCIA
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP