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Amphiregulin Versus Non-Amphiregulin Supplementation to Maturation Culturing Medium in IVM.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915054
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mỹ Đức Hospital

Brief Summary:

Clinical use of IVM was pioneered in the nineties, but has not yet become a realistic option for wide-scale practice, for several reasons. Fundamentally, despite recent progress in improving the implantation and the pregnancy rates using in-vitro matured oocytes, results of IVM remain lower than treatment cycles utilizing conventional ART. To improve the outcome of IVM cycles, this study focuses on improving in-vitro culture conditions.

In-vitro maturation (IVM) of human oocytes obtained from minimally stimulated or unstimulated ovaries offers a more "patient friendly" treatment option than the conventional Assisted Reproductive Technology (ART) treatment with controlled ovarian hyperstimulation (COH). Typically, IVM will be offered to women with polycystic ovaries (PCO/PCOS), or to patients with an excellent ovarian reserve, i.e. a high antral follicle count. IVM treatment is characterized by minimal administration of FSH or hMG and NO hCG trigger. The IVM approach is less disruptive to patients' daily life through the reduced need for hormonal and ultrasound monitoring, avoids a range of minor and major complications, such as ovarian hyperstimulation syndrome, and aims to reduce the total cost of infertility treatment for the patient and for the health care budget.

Human oocytes retrieved from small antral follicles are able to resume meiosis by undergoing germinal vesicle breakdown and extrusion of the first polar body, if oocytes have reached meiotic competence. These oocytes can be fertilized although only a proportion (less than 50%) of them can develop further into viable embryos. It has been hypothesized that failure of embryonic development may, at least in part, be due to an immature oocyte cytoplasm. A novel human in vitro maturation (IVM) culture system (named CAPACITATION-IVM is being investigated, hereafter named "CAPA") using 1°) natural compounds known to influence cAMP levels within the cumulus-oocyte-complex and 2°) compounds that are crucial for the oocyte-cumulus cross-talk. Keeping cyclic AMP high after retrieval in the GV oocyte prevents occurrence of nuclear maturation, enabling increased communication between the oocyte and the cumulus cells. This allows for the improvement in the synchronization of nuclear and cytoplasmic maturation processes in the oocyte, to the benefit of embryo quality.


Condition or disease Intervention/treatment Phase
PCOS IVM Drug: AREG-IVM medium Drug: STD medium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the CAPA Culture Step on Meiotic and Developmental Competence of Human Oocytes After Using Two (Previously Used) Meiotic Maturation Triggers in a SIBLING Oocyte Study Design
Actual Study Start Date : April 14, 2019
Actual Primary Completion Date : December 12, 2019
Actual Study Completion Date : January 31, 2020

Arm Intervention/treatment
Active Comparator: AREG-IVM

Per case (6mL) 5940 µL "Basal Medium"

  • 60 µL "IVM MIX" Do not need to filtrate media.
Drug: AREG-IVM medium

Oocytes in CAPA-IVM medium will be mature in AREG+FSH medium. Per case (6mL) 5940 µL "Basal Medium"

  • 60 µL "IVM MIX" Do not need to filtrate media.
Other Name: Capacitation IVM medium

Active Comparator: STD-IVM
Per case (5 mL) 4.3 ml IVM Medicult Medium (Vial 2) 0.5 ml HSA (from stock 10% solution) 50µl FSH (from stock 7.5 IU/ml) 5µl hCG (from stock 100 IU/ml) 75 µl GH (from stock 0.66mg/ml)
Drug: STD medium
Oocytes in CAPA-IVM medium will be mature in FSH+hCG+GH medium. Per case (5 mL) 4.3 ml IVM Medicult Medium (Vial 2) 0.5 ml HSA (from stock 10% solution) 50µl FSH (from stock 7.5 IU/ml) 5µl hCG (from stock 100 IU/ml) 75 µl GH (from stock 0.66mg/ml)
Other Name: Standard IVM medium




Primary Outcome Measures :
  1. Meiotic maturation efficiency [ Time Frame: Two days after oocytes pick-up ]
    Percentage of PB, GVBD, GV by the two types of trigger. The PB (or MII) oocyte displays the first PB in the PVS. GVBD oocytes have neither a visible GV nor PBI. GV oocyte presents an intracytoplasmic nucleus called the 'germinal vesicle'.

  2. Number of transferable day 3 embryos [ Time Frame: Five days after oocytes pick-up ]
    Number of transferable day 3 embryos obtained by the two meiotic trigger types


Secondary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: At a minimum of 12 weeks from the beginning of the last menstrual cycle (each cycle is 4 weeks) up to the time of delivery ]
    Pregnancy with detectable heart rate at 12 weeks' gestation up to the time of delivery

  2. Live birth rate [ Time Frame: At least 24 weeks of gestation up to the time of delivery ]
    Live birth is defined as the birth of at least one newborn after 24 weeks' gestation that exhibits any sign of life (twin will be a single count). For the timing of this occur, ongoing pregnancy will be used, i.e. ongoing pregnancy at 12 weeks will be used in calculations, conditional on the fact that this ongoing pregnancy results in live birth.

  3. Genetic and epigenetic analysis of cord blood of newborns [ Time Frame: 1 day (Prior to the initiation of IVF/IVM) and 1 day (at the time of delivery) ]
    Newborn's material (cord blood) will be collected for genetics (karyotyping) and epigenetics analysis.

  4. Genetic and epigenetic analysis of cells from buccal smears of newborns [ Time Frame: 1 day (Prior to the initiation of IVF/IVM) and 1 day (at the time of delivery) ]
    Newborn's material (cells from buccal smears) will be collected for genetics (karyotyping) and epigenetics analysis.

  5. Genetic and epigenetic analysis of placenta of newborns [ Time Frame: 1 day (Prior to the initiation of IVF/IVM) and 1 day (at the time of delivery) ]
    Newborn's material (placenta) will be collected for genetics (karyotyping) and epigenetics analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having polycystic ovarian morphology: at least 25 follicles (2-9 mm) throughout the whole ovary and/or increased ovarian volume (>10ml) (it is sufficient that 1 ovary fits these criteria)
  • No major uterine or ovarian abnormalities

Exclusion Criteria:

  • Medical contra-indication for pregnancy
  • High (>grade 2) grade endometriosis
  • Cases with extremely poor sperm (OAT)

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): NCT03915054


Locations
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Vietnam
My Duc Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Mỹ Đức Hospital
Investigators
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Principal Investigator: Tuong M Ho, MD,MCE Hope Research Center
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Responsible Party: Mỹ Đức Hospital
ClinicalTrials.gov Identifier: NCT03915054    
Other Study ID Numbers: CS/BVMD/19/03
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No