In Vitro Fertilization Clinical Trial
Official title:
CAPA-IVM Culture With Low Oxygen Tension
Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility | Inclusion Criteria: - 18-42 years of age - Diagnosed with polycystic ovary syndrome according to the Rotterdam criteria (2003) - Indicating CAPA-IVM treatment - Having at least 40 antral follicles in two ovaries by transvaginal ultrasound at the time of CAPA-IVM indication - Agreeing to have frozen embryo transfer - Agreeing to participate in the trial Exclusion Criteria: - Cycles with oocyte donation, preimplantation Genetic Testing (PGT) - Couples with severe male factor (sperm concentration <5 million/ml, motility < 10%), surgical sperm retrieval - Previous history of unexplained immature oocytes after IVF treatment - Uterine abnormalities |
Country | Name | City | State |
---|---|---|---|
Vietnam | My Duc Hospital | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
M? Ð?c Hospital | Vrije Universiteit Brussel |
Vietnam,
Akin N, Ates G, von Mengden L, Herta AC, Meriggioli C, Billooye K, Stocker WA, Ghesquiere B, Harrison CA, Cools W, Klamt F, Massie A, Smitz J, Anckaert E. Effects of lactate, super-GDF9, and low oxygen tension during bi-phasic in vitro maturation on the bioenergetic profiles of mouse cumulus-oocyte complexdagger. Biol Reprod. 2023 Oct 13;109(4):432-449. doi: 10.1093/biolre/ioad085. — View Citation
Bahrami M, Cottee PA. Culture conditions for in vitro maturation of oocytes - A review. Reproduction and Breeding. 2022 Jun 1;2(2):31-6
Fischer B, Bavister BD. Oxygen tension in the oviduct and uterus of rhesus monkeys, hamsters and rabbits. J Reprod Fertil. 1993 Nov;99(2):673-9. doi: 10.1530/jrf.0.0990673. — View Citation
Gilchrist RB, Ho TM, De Vos M, Sanchez F, Romero S, Ledger WL, Anckaert E, Vuong LN, Smitz J. A fresh start for IVM: capacitating the oocyte for development using pre-IVM. Hum Reprod Update. 2024 Jan 3;30(1):3-25. doi: 10.1093/humupd/dmad023. — View Citation
Herta AC, von Mengden L, Akin N, Billooye K, Coucke W, van Leersum J, Cava-Cami B, Saucedo-Cuevas L, Klamt F, Smitz J, Anckaert E. Characterization of carbohydrate metabolism in in vivo- and in vitro-grown and matured mouse antral folliclesdagger. Biol Reprod. 2022 Oct 11;107(4):998-1013. doi: 10.1093/biolre/ioac124. — View Citation
Increased susceptibility to oxidative stress as a proximate cost of reproduction - Alonso-Alvarez - 2004 - Ecology Letters - Wiley Online Library [Internet]. [cited 2023 Sep 19]. Available from: https://onlinelibrary.wiley.com/doi/10.1111/j.1461-0248.2004.00594.x
Paulson RJ, Fauser BCJM, Vuong LTN, Doody K. Can we modify assisted reproductive technology practice to broaden reproductive care access? Fertil Steril. 2016 May;105(5):1138-1143. doi: 10.1016/j.fertnstert.2016.03.013. Epub 2016 Apr 4. — View Citation
Practice Committees of the American Society for Reproductive Medicine, the Society of Reproductive Biologists and Technologists, and the Society for Assisted Reproductive Technology. Electronic address: jgoldstein@asrm.org. In vitro maturation: a committee opinion. Fertil Steril. 2021 Feb;115(2):298-304. doi: 10.1016/j.fertnstert.2020.11.018. Epub 2020 Dec 24. — View Citation
Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098. — View Citation
Vuong LN, Ho VNA, Ho TM, Dang VQ, Phung TH, Giang NH, Le AH, Pham TD, Wang R, Smitz J, Gilchrist RB, Norman RJ, Mol BW. In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial. Hum Reprod. 2020 Nov 1;35(11):2537-2547. doi: 10.1093/humrep/deaa240. — View Citation
Zhao X, Liu X, Feng Y, Shi D, Lu F. Regulation of hypoxia-inducible factor 1alpha by optimal oxygen concentration enhances oocyte maturation and early embryonic development in buffalo. Theriogenology. 2023 Aug;206:50-59. doi: 10.1016/j.theriogenology.2023.05.006. Epub 2023 May 8. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maturation rate | The oocyte maturation rate was usually defined by MII oocyte number divided by total COCs number | Two day after oocyte retrieval | |
Secondary | Total number of oocytes retrieval | Counting the number of oocytes retrieved | On the day of oocyte retrieval | |
Secondary | Number of patients with no oocyte retrieved | Counting the number of patients with no oocyte retrieved | On the day of oocyte retrieval | |
Secondary | Number of MII oocytes | The oocyte maturation was usually defined by MII oocyte number | Two day after oocyte retrieval | |
Secondary | Number of GV oocytes | Counting the number of GV oocytes | Two day after oocyte retrieval | |
Secondary | Number of patients with no matured oocyte | Counting the number of patients with no matured oocyte | Two day after oocyte retrieval | |
Secondary | Number of 2PN oocytes | Number of zygotes with 2 pronuclei after ICSI | 16-18 hours after ICSI | |
Secondary | Fertilization rate | Number of fertilized oocytes / number of oocytes inseminated | 16-18 hours after ICSI | |
Secondary | Abnormal fertilization rate | The percentage of zygotes with 1,3, or 4 pronuclei after ICSI / number of oocytes inseminated | 16-18 hours after ICSI | |
Secondary | Number of patients with no day-3 embryo | Counting the number of patients with no embryo | Five day after oocyte retrieval | |
Secondary | Number of day-3 embryos | Counting the number of day-3 embryos at 64±2h after ICSI | Three days after intra-cytoplasmic sperm injection | |
Secondary | Number of good quality Day-3 embryos | Number of grade 1 and grade 2 day-3 embryos | Three days after intra-cytoplasmic sperm injection | |
Secondary | Number of frozen day-3 embryos | Counting the numer of frozen day-3 embryos | Three days after ICSI | |
Secondary | Number of blastocyst (day 5 or day 6 embryo) | Counting the number of blastocyst at 114±2h/140±2h after ICSI | Five or six days after ICSI | |
Secondary | Number of patients with no blastocyst | Counting the number of patients with no blastocyst | Five or six days after ICSI | |
Secondary | Number of good quality blastocysts | Number of grade 1 and grade 2 blastocysts | Five days after intra-cytoplasmic sperm injection | |
Secondary | Number of frozen blastocysts | Counting the numer of frozen blastocysts | Three days after ICSI | |
Secondary | Number of embryos transferred | Total embryos transferred | On the day of embryo transfer | |
Secondary | Quality of embryos transferred (Grade 1, Grade 2, Grade 3) | The quality of transferred embryo is classified according to Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology, 2011; D. Gardner, 1999; D. K. Gardner & Schoolcrati, 1999 | On the day of embryo transfer | |
Secondary | Positive pregnancy test rate | Positive pregnancy test defined as serum human chorionic gonadotropin level greater than 25 mIU/mL | 11 days after the day of blastocyst transfer and 13 days after the day of day-3 embryo transfer | |
Secondary | Implantation rate | Implantation rate is explained as the number of gestational sacs per number of embryos transferred. | At 3 weeks after embryo transfer after the completion of the embryo transfer | |
Secondary | Clinical pregnancy rate | Diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy at 6 weeks or more after the onset of last menstrual period. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy | 5 weeks after embryo transfer | |
Secondary | Ectopic pregnancy rate | A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology | 3 weeks after embryo transfer | |
Secondary | Ongoing pregnancy rate | Ongoing pregnancy is defined as pregnancy with a detectable heart rate at 12 weeks' gestation or beyond. | 10 weeks after embryo transfer | |
Secondary | Miscarriage <12 weeks rate (Early miscarriage) | Spontaneous loss of pregnancy up to 12 weeks of gestation is referred to as an early | 2-10 weeks after embryo transfer | |
Secondary | Miscarriage <22 weeks rate (late miscarriage) | Spontaneous loss of pregnancy between 12 to 22 weeks is termed as late miscarriage | At >10 to 20 weeks after the transfer | |
Secondary | Live birth rate | Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Twins counted as one live birth. | At 22 weeks of gestation | |
Secondary | Multiple pregnancy rate | Defined as the presence of more than one gestational sac at early pregnancy ultrasound (6-9 weeks gestation) | 4 weeks after embryo transfer | |
Secondary | Multiple delivery rate | Defined as the complete expulsion or extraction from a woman of more than one fetus, after 22 completed weeks of gestational age, irrespective of whether it is a live birth or stillbirth | At 22 weeks' gestation | |
Secondary | Mode of delivery | Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor) | At birth | |
Secondary | Gestational age at birth | Calculated by gestational age of all live births | At birth | |
Secondary | Birth weight | in grams; of singletons and twins | At the time of delivery | |
Secondary | Very low birth weight rate | Birth weight less than 1.500 g | At birth | |
Secondary | Low birth weight rate | Birth weight less than 2.500 g | At birth | |
Secondary | High birth weight rate | Implies growth beyond an absolute birth weight, historically 4.000 g or 4.500 g, regardless of the gestational age | At birth | |
Secondary | Very high birth weight rate | Birth weight over than 4.500 g for women with diabetes, and a threshold of 5000 g for women without diabetes | At birth | |
Secondary | Small for gestational age rate | Large for gestational age was defined as a birth weight below the 10th percentile | At birth | |
Secondary | Large for gestational age rate | Large for gestational age was defined as a birth weight above the 90th percentile | At birth | |
Secondary | Hypertension in pregnancy rate | Comprising pregnancy-induced hypertension (PIH), pre-eclampsia (PET), eclampsia, and HELLP syndrome. | At 20 weeks of gestation or beyond | |
Secondary | Gestational diabetes mellitus rate | Diagnosed according to the latest version of ADA guidelines. a 75-g OGTT, with plasma glucose measurement when patient is fasting and at 1 and 2 h, at 24-28 weeks of gestation in women not previously diagnosed with diabetes.
Fasting: 92 mg/dL (5.1 mmol/L) 1 h: 180 mg/dL (10.0 mmol/L) 2 h: 153 mg/dL (8.5 mmol/L) |
At 24 to 28 weeks of gestation | |
Secondary | Still birth rate | defined as the death of a fetus prior to the complete expulsion or extraction from its mother after 20 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles. It includes deaths occurring during labor | After 20 completed weeks of gestational age | |
Secondary | Premature birth rate | Defined as delivery at <24, <28, <32, <37 completed weeks. A birth that takes place after 22 weeks and before 37 completed weeks of gestational age. | On the day of delivery | |
Secondary | Antepartum haemorrhage rate | Defined as bleeding from or into the genital tract, occurring from 24 weeks of pregnancy and prior to the birth of the baby. | At birth | |
Secondary | Major congenital abnormalities rate | Structural, functional, and genetic anomalies, that occur during pregnancy, and identified antenatally, at birth, or later in life, and require surgical repair of a defect, or are visually evident, or are life-threatening, or cause death. Any congenital anomaly will be included as followed definition of congenital abnormalities in Surveillance of Congenital Anomalies by Division of Birth Defects and Developmental Disabilities, NCBDDD, Centers for Disease Control and Prevention (2020). | At birth | |
Secondary | Neonatal mortality rate | Neonatal mortality defined as the death of a live-born baby within 28 days of birth. This can be divided into early neonatal mortality, if death occurs in the first seven days after birth, and late neonatal if death occurs between eight and 28 days after delivery | between eight and 28 days after delivery | |
Secondary | NICU admission rate | Counting number of babies admited to neonatal intensive care unit | At birth | |
Secondary | Reason for NICU admission | Respiratory distress, Intraventricular Hemorrhage, Necrotizing enterocolitis, Sepsis | At birth |
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