IVF Clinical Trial
Official title:
Effect of Single vs. Group CAPA-IVM Culture of Human Cumulus-oocyte Complexes From Small Antral Follicles in a SIBLING Oocyte Study Design
Verified date | July 2023 |
Source | M? Ð?c Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Oocyte in vitro maturation (IVM) is a minimal-stimulation ART with reduced hormone-related side effects and risks for the patients. However, the approach is not widely used because of an efficiency gap compared to conventional ART. In order to further optimize and adapt the CAPA-IVM system in the IVM clinic, this pilot study aims to check the feasibility of applying a single COC CAPA-IVM strategy versus the group COC culture CAPA-IVM
Status | Completed |
Enrollment | 15 |
Est. completion date | October 24, 2021 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 37 Years |
Eligibility | 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 - Having at least 15 follicles on the OPU day - Patients consent to participate in the study Exclusion Criteria: - High (>grade 2) grade endometriosis - Cases with extremely poor sperm (serve OAT: density <1 million, mobility <10% and sperm from testicular surgery) |
Country | Name | City | State |
---|---|---|---|
Vietnam | My Duc Hospital | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
M? Ð?c Hospital |
Vietnam,
Saenz-de-Juano MD, Ivanova E, Billooye K, Herta AC, Smitz J, Kelsey G, Anckaert E. Genome-wide assessment of DNA methylation in mouse oocytes reveals effects associated with in vitro growth, superovulation, and sexual maturity. Clin Epigenetics. 2019 Dec 19;11(1):197. doi: 10.1186/s13148-019-0794-y. Erratum In: Clin Epigenetics. 2020 Jan 27;12(1):18. — View Citation
Sanchez F, Le AH, Ho VNA, Romero S, Van Ranst H, De Vos M, Gilchrist RB, Ho TM, Vuong LN, Smitz J. Biphasic in vitro maturation (CAPA-IVM) specifically improves the developmental capacity of oocytes from small antral follicles. J Assist Reprod Genet. 2019 Oct;36(10):2135-2144. doi: 10.1007/s10815-019-01551-5. Epub 2019 Aug 9. — View Citation
Sanchez F, Lolicato F, Romero S, De Vos M, Van Ranst H, Verheyen G, Anckaert E, Smitz JEJ. An improved IVM method for cumulus-oocyte complexes from small follicles in polycystic ovary syndrome patients enhances oocyte competence and embryo yield. Hum Repr — View Citation
Sanchez F, Romero S, De Vos M, Verheyen G, Smitz J. Human cumulus-enclosed germinal vesicle oocytes from early antral follicles reveal heterogeneous cellular and molecular features associated with in vitro maturation capacity. Hum Reprod. 2015 Jun;30(6):1396-409. doi: 10.1093/humrep/dev083. Epub 2015 Apr 22. — View Citation
Vuong LN, Le AH, Ho VNA, Pham TD, Sanchez F, Romero S, De Vos M, Ho TM, Gilchrist RB, Smitz J. Live births after oocyte in vitro maturation with a prematuration step in women with polycystic ovary syndrome. J Assist Reprod Genet. 2020 Feb;37(2):347-357. doi: 10.1007/s10815-019-01677-6. Epub 2020 Jan 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of good quality embryos | Number of good quality Day 3 embryos obtained | At least 3 days after intra-cytoplasmic sperm injection | |
Secondary | Maturation rate | Percentage of mature oocytes by 2 types of COC culture | Two days after oocytes pick-up | |
Secondary | Fertilization rate | Percentage of fertilized oocytes by 2 types of COC culture | 16-18 hours after intra-cytoplasmic sperm injection | |
Secondary | Cleavage rate | Percentage of day-3 embryos over fertilized oocytes by 2 types of COC culture | At least 3 days after intra-cytoplasmic sperm injection | |
Secondary | Expansion rate | Percentage of cumulus-oocyte complexes expanded after culture by 2 types of COC culture | After at least 30 hours of maturation culture | |
Secondary | The relative expression ratio ( R ) of human cumulus cell genes | Cumulus cells will be collected, cDNA synthesis after mRNA purification, relative quantification PCR for detecting gene expression | cumulus cells will be collected after at least 30 hours of maturation culture, storaged at -80oC until RNA purification | |
Secondary | Positive pregnancy test | Serum human chorionic gonadotropin level greater than 25 mIU/mL | at 2 weeks after the embryo placement after the completion of the first transfer | |
Secondary | Clinical pregnancy | at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity | 5 weeks after embryo placement after the completion of the first transfer | |
Secondary | Ongoing pregnancy | Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer | At 12 weeks' gestation | |
Secondary | Implantation rate | as the number of gestational sacs per number of embryos transferred | 3 weeks after embryo transferred after the completion of the first transfer | |
Secondary | Multiple pregnancy | Defined as presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation) | 5 weeks after embryo placement after the completion of the first transfer | |
Secondary | Multiple delivery | Birth of more than one baby beyond 24 weeks | At 24 weeks' gestation | |
Secondary | Miscarriage | pregnancy loss at < 24 weeks | at 24 weeks of gestation after the completion of the first transfer | |
Secondary | Live birth | defined as at least one newborn after 24 weeks of gestation and exhibiting any sign of life; twins were counted as a single birth | At 24 weeks of gestation |
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