Clinical trial NCT04297553: Fresh Versus Freeze-only After CAPA IVM on PCOS Patients
Official title: Outcomes of Fresh Transfer Versus Freeze-only After CAPA IVM on PCOS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
IVM
Embryo Transfer
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle.
timeFrame: At 24 weeks of gestation
Secondary outcomes:
measure: Positive pregnancy test
timeFrame: at 2 weeks after the embryo placement after the completion of the first transfer
measure: Clinical pregnancy
timeFrame: 5 weeks after embryo placement after the completion of the first transfer
measure: Implantation rate
timeFrame: 3 weeks after embryo transferred after the completion of the first transfer
measure: Ongoing pregnancy
timeFrame: At 12 weeks' gestation
measure: Number of embryos on day 3
timeFrame: 5 days after oocytes pick-up
measure: Number of good quality embryo on day 3
timeFrame: 5 days after oocytes pick-up
measure: Time from randomisation to ongoing pregnancy
timeFrame: 12 weeks of gestation after the completion of the first transfer
measure: Time from randomisation to live birth
timeFrame: At the time of delivery
measure: Ovarian hyperstimulation syndrome (OHSS)
timeFrame: at 03 days after oocytes pick-up and 14 days after embryo transfer
measure: Ectopic pregnancy
timeFrame: at 12 weeks of gestation after the completion of the first transfer
measure: Miscarriage
timeFrame: at 24 weeks of gestation after the completion of the first transfer
measure: Hypertensive disorders of pregnancy
timeFrame: at 20 weeks of gestation or beyond after the completion of the first transfer
measure: Gestational diabetes mellitus
timeFrame: at 24 weeks of gestation after the completion of the first transfer
measure: Preterm delivery
timeFrame: at 24, 28, 32 weeks and 37 weeks of gestation after the completion of the first transfer
measure: Multiple pregnancy
timeFrame: 5 weeks after embryo placement after the completion of the first transfer
measure: Birth weight
timeFrame: at the time of delivery
measure: Congenital anomaly
timeFrame: At birth after the completion of the first transfer
measure: Cost-effectiveness
timeFrame: Two year after randomization
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Mỹ Đức Hospital
state: Tan Binh
Study officials:
affiliation: Mỹ Đức Hospital
name: Lan N Vuong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vuong LN, Nguyen LK, Le AH, Pham HH, Ho VN, Le HL, Pham TD, Dang VQ, Phung TH, Smitz J, Ho TM. Fresh embryo transfer versus freeze-only after in vitro maturation with a pre-maturation step in women with high antral follicle count: a randomized controlled pilot study. J Assist Reprod Genet. 2021 Jun;38(6):1293-1302. doi: 10.1007/s10815-021-02180-7. Epub 2021 Apr 6.