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
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Female||Drug: CAPA-IVM Drug: Standard-IVM||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|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)|
|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|
Active Comparator: CAPA-IVM
Immature oocytes are culture in the new capacitation-IVM system.
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.
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.
- 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.
- 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
- 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
- Number of oocytes retrieved [ Time Frame: Maximum at 30 minutes after oocyte retrieval procedure ]The number of oocyte identified after oocyte retrieval
- Oocyte maturation rate [ Time Frame: After at least 30 hours of maturation culture ]Rate of mature oocytes on culture oocytes
- Number of fertilized oocytes [ Time Frame: 16-18 hours after intra-cytoplasmic sperm injection ]Number of fertilized oocyte after sperm insemination
- Number of embryos [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]Number of cleavage embryos obtained
- Number of good quality embryos [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]Number of good cleavage embryos obtained
- Number of embryos frozen [ Time Frame: At least 3 days after intra-cytoplasmic sperm injection ]Number of cleavage embryos frozen
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
|My Duc Hospital|
|Ho Chi Minh City, Vietnam, 70000|
|Principal Investigator:||Tuong M Ho, MD||HOPE Research Center|