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CAPA-IVM Versus STANDARD IVM

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ClinicalTrials.gov Identifier: NCT03921710
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Mỹ Đức Hospital

Brief Summary:
The aim of this study is to evaluate the effectiveness and safety of CAPA-IVM versus standard IVM in women with polycystic ovarian morphology (PCOM) or polycystic ovary syndrome (PCOS) .

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: CAPA-IVM Drug: Standard-IVM Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized Clinical Trial

Patients are randomized to either CAPA-IVM or STANDARD-IVM using block randomization by an independent study coordinator using a computer-generated random list (block size 4) on the second day of their periods.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research Study to Evaluate Capacitation Culture (CAPA) Followed by in Vitro Maturation (IVM) of Human Oocytes: A Randomized Pilot Study
Actual Study Start Date : April 29, 2017
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CAPA-IVM
Immature oocytes are culture in the new capacitation-IVM system.
Drug: CAPA-IVM
Immature oocytes were plated into a 4-well dish (Nunc, Denmark) at 10 COCs/well using CAPA medium (Medicult IVM medium; Origio, Denmark supplemented with 1 mIU/mL rFSH, 5 ng/mL insulin, 10 nM estradiol, 10 mg/mL human serum albumin [SAGE, Denmark] and 25 nM CNP under oil for 24 h at 37°C, 6% carbon dioxide in air). After 24 hours, COCs were washed and transferred into IVM medium (Origio, Denmark) containing 5 ng/mL insulin, 10 nM estradiol, 100 ng/mL human recombinant amphiregulin and 100 mIU/mL rFSH, and incubated under oil for 30 h at 37°C, 6% carbon dioxide in air.

Active Comparator: Standard-IVM
Immature oocytes are cultured in the standard IVM system.
Drug: Standard-IVM
Immature oocytes are plated into a 4-well dish at 10 COCs/well using IVM medium supplemented with 75 mIU/mL recombinant FSH (Merck, Switzerland), 100 mIU/mL hCG (MSD, USA), 0.01 mg/mL growth hormone (Merck, Switzerland) and 10 mg/mL human serum albumin (SAGE, Denmark). COCs were incubated for 30 hours at 37°C, 6% carbon dioxide in air.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: At a minimum of 12 weeks from the beginning of the last menstrual cycle ]
    Pregnancy with detectable heart rate at 12 weeks' gestation

  2. Clinical pregnancy rate [ Time Frame: At a minimum of 12 weeks from the beginning of the last menstrual cycle ]
    Pregnancy with detectable gestational sac at 7 weeks' gestation

  3. Number of oocytes retrieved [ Time Frame: Maximum at 30 minutes after oocyte retrieval procedure ]
    The number of oocyte identified after oocyte retrieval

  4. Oocyte maturation rate [ Time Frame: After at least 30 hours of maturation culture ]
    Rate of mature oocytes on culture oocytes

  5. Number of fertilized oocytes [ Time Frame: 16-18 hours after intra-cytoplasmic sperm injection ]
    Number of fertilized oocyte after sperm insemination

  6. Number of embryos [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]
    Number of cleavage embryos obtained

  7. Number of good quality embryos [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]
    Number of good cleavage embryos obtained

  8. Number of embryos frozen [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]
    Number of cleavage embryos frozen



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Ages Eligible for Study:   up to 37 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Wives in infertile couples
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • < 38 years
  • PCOS patients with 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:

  • High (>grade 2) grade endometriosis
  • Cases with extremely poor sperm (OAT) such as azoospermia or cryptozoospermia

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): NCT03921710


Locations
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Vietnam
My Duc Hospital
Ho Chi Minh City, Vietnam, 70000
Sponsors and Collaborators
Mỹ Đức Hospital
Investigators
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Principal Investigator: Tuong M Ho, MD HOPE Research Center

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Responsible Party: Mỹ Đức Hospital
ClinicalTrials.gov Identifier: NCT03921710     History of Changes
Other Study ID Numbers: 17-2017/QD-CGRH-NCKH&DT
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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

Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female