An interventional study of CAPA-Fresh and CAPA-Freeze-only in PCOS, IVM and Embryo Transfer, sponsored by Mỹ Đức Hospital. Completed at 1 site in Vietnam. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Mỹ Đức Hospital · Not applicable, Interventional, and Treatment
IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS (polycystic ovary syndrome) patients compared with conventional controlled ovarian stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter treatment duration, lower cost, and acceptable pregnancy outcomes.
IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS (polycystic ovary syndrome) patients compared with conventional controlled ovarian stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter treatment duration, lower cost, and acceptable pregnancy outcomes. CAPA (capacitation) IVM without hCG (human chorionic gonadotropin) priming, has routinely been used at My Duc hospital for nearly 3 years to replace hCG-IVM (with hCG priming) because of absolutely synchronized oocyte maturation stage and better embryo results and better pregnancy outcomes. However, with CAPA IVM, embryos are freezed-only and will be transferred in the next cycles. This process will increase the cost of freezing and thawing embryos, and increase the treatment duration, which complicates the IVM procedure and turns IVM into an unfriendly protocol to PCOS patients. Therefore, our group conducts this study to find out the effectiveness of fresh transfer protocol after CAPA IVM compared with freezing-only CAPA IVM protocol. The fresh transfer protocol for CAPA IVM is applied from previous hCG IVM protocol, with the use of hCG and exogenous estradiol and progesterone, but at different timings.
Mỹ Đức Hospital is the lead sponsor of 55 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Receiving hCG 5000IU x 2 (10000IU) after Oocytes retrieval. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Fresh embryos transfer will be performed on day 3 using HRT protocol with a maximum of 2 embryos transferred.
Procedure: CAPA-Fresh
Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred
Procedure: CAPA-Freeze-only
Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Receiving hCG 5000IU x 2 (10000IU) after Oocytes retrieval. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Fresh embryos transfer will be performed on day 3 using HRT protocol with a maximum of 2 embryos transferred.
Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred.
Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle.
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, conditional on the fact that this ongoing pregnancy results in live birth.
Time frame: At 24 weeks of gestation
Positive pregnancy test
Serum human chorionic gonadotropin level greater than 5 mIU/mL
Time frame: at 2 weeks after the embryo placement after the completion of the first transfer
Clinical pregnancy
at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity
Time frame: 5 weeks after embryo placement after the completion of the first transfer
Implantation rate
as the number of gestational sacs per number of embryos transferred
Time frame: 3 weeks after embryo transferred after the completion of the first transfer
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
Time frame: At 12 weeks' gestation
Number of embryos on day 3
Number of embryos on day 3
Time frame: 5 days after oocytes pick-up
Number of good quality embryo on day 3
good quality embryos are defined followed Istanbul consensus
Time frame: 5 days after oocytes pick-up
Time from randomisation to ongoing pregnancy
Time from randomization to ongoing pregnancy after the completion
Time frame: 12 weeks of gestation after the completion of the first transfer
Time from randomisation to live birth
Time from randomization to live birth after the completion
Time frame: At the time of delivery
Ovarian hyperstimulation syndrome (OHSS)
Routine assessments for OHSS were performed on day 3 post oocyte retrieval in both groups. At other times, OHSS was evaluated if symptoms were reported by the patient. OHSS was classified using the flow diagram developed by Humaidan and colleagues for use in clinical trial settings
Time frame: at 03 days after oocytes pick-up and 14 days after embryo transfer
Ectopic pregnancy
a pregnancy in which implantation takes place outside the uterine cavity after the completion of the first transfer
Time frame: at 12 weeks of gestation after the completion of the first transfer
Miscarriage
pregnancy loss at \< 24 weeks
Time frame: at 24 weeks of gestation after the completion of the first transfer
Hypertensive disorders of pregnancy
Pregnancy-induced hypertension, pre-eclampsia and eclampsia
Time frame: at 20 weeks of gestation or beyond after the completion of the first transfer
Gestational diabetes mellitus
using a 75g oral glucose tolerance test
Time frame: at 24 weeks of gestation after the completion of the first transfer
Preterm delivery
Multiple definitions, defined as delivery at \<24, \<28, \<32, \<37 completed weeks
Time frame: at 24, 28, 32 weeks and 37 weeks of gestation after the completion of the first transfer
Multiple pregnancy
Defined as presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation)
Time frame: 5 weeks after embryo placement after the completion of the first transfer
Birth weight
Weight of singletons and twins
Time frame: at the time of delivery
Congenital anomaly
Any congenital anomaly will be included
Time frame: At birth after the completion of the first transfer
Cost-effectiveness
Including direct and indirect costs; costs related to complications treatment. Cost data will be collected for a supplementary analysis and will be reported in a separated paper.
Time frame: Two year after randomization
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Mỹ Đức Hospital