Fresh Versus Freeze-only After CAPA IVM on PCOS Patients

Mỹ Đức Hospital

Status: Completed

Conditions: PCOS; Embryo Transfer; IVM

Treatments: Procedure: CAPA-Fresh; Procedure: CAPA-Freeze-only

Study type: Interventional

Funder types: Other

Identifiers

NCT04297553

CS/BVMĐPN/20/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

CAPA-Fresh

Active Comparator group

Description:

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.

Treatment:

Procedure: CAPA-Fresh

CAPA-Freeze-only

Active Comparator group

Description:

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

Treatment:

Procedure: CAPA-Freeze-only