Embryo Transfer, IVM, PCOS
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECAPA-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. 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.
PROCEDURECAPA-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. 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.
Sponsors
Mỹ Đức Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Women with high AFC (≥24 Antral Follicles in Both Ovaries), including PCOS plus PCO or high AFC * Having indications for ART * Having ≤ 2 IVM/IVF attempts * Permanent resident in Vietnam * Agree to have fresh embryos transfer or freeze-only on day 3 * Agree to have ≤ 2 embryos transferred * Not participating in another IVF study at the same time
Exclusion criteria
* Oocyte donation cycles * Pre-implantation genetic diagnosis (PGD) cycles
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle. | At 24 weeks of gestation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 5 weeks after embryo placement after the completion of the first transfer | at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity |
| Implantation rate | 3 weeks after embryo transferred after the completion of the first transfer | as the number of gestational sacs per number of embryos transferred |
| Ongoing pregnancy | At 12 weeks' gestation | Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer |
| Number of embryos on day 3 | 5 days after oocytes pick-up | Number of embryos on day 3 |
| Number of good quality embryo on day 3 | 5 days after oocytes pick-up | good quality embryos are defined followed Istanbul consensus |
| Time from randomisation to ongoing pregnancy | 12 weeks of gestation after the completion of the first transfer | Time from randomization to ongoing pregnancy after the completion |
| Time from randomisation to live birth | At the time of delivery | Time from randomization to live birth after the completion |
| Ovarian hyperstimulation syndrome (OHSS) | at 03 days after oocytes pick-up and 14 days after embryo transfer | 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 |
| Positive pregnancy test | at 2 weeks after the embryo placement after the completion of the first transfer | Serum human chorionic gonadotropin level greater than 5 mIU/mL |
| Miscarriage | at 24 weeks of gestation after the completion of the first transfer | pregnancy loss at \< 24 weeks |
| Hypertensive disorders of pregnancy | at 20 weeks of gestation or beyond after the completion of the first transfer | Pregnancy-induced hypertension, pre-eclampsia and eclampsia |
| Gestational diabetes mellitus | at 24 weeks of gestation after the completion of the first transfer | using a 75g oral glucose tolerance test |
| Preterm delivery | at 24, 28, 32 weeks and 37 weeks of gestation after the completion of the first transfer | Multiple definitions, defined as delivery at \<24, \<28, \<32, \<37 completed weeks |
| Multiple pregnancy | 5 weeks after embryo placement after the completion of the first transfer | Defined as presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation) |
| Birth weight | at the time of delivery | Weight of singletons and twins |
| Congenital anomaly | At birth after the completion of the first transfer | Any congenital anomaly will be included |
| Cost-effectiveness | Two year after randomization | 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. |
| Ectopic pregnancy | at 12 weeks of gestation after the completion of the first transfer | a pregnancy in which implantation takes place outside the uterine cavity after the completion of the first transfer |
Countries
Vietnam
Outcome results
None listed