Fresh Versus Freeze-only After CAPA IVM on PCOS Patients

NCT04297553 | Completed

• 1 other identifier: CS/BVMĐPN/20/01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; IVM; Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• 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.

  At 24 weeks of gestation

Secondary Outcomes (18)

• Positive pregnancy test

  at 2 weeks after the embryo placement after the completion of the first transfer

• Clinical pregnancy

  5 weeks after embryo placement after the completion of the first transfer

• Implantation rate

  3 weeks after embryo transferred after the completion of the first transfer

• Ongoing pregnancy

  At 12 weeks' gestation

• Number of embryos on day 3

  5 days after oocytes pick-up

Study Arms (2)

CAPA-Fresh

ACTIVE COMPARATOR

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

CAPA-Freeze-only

ACTIVE COMPARATOR

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

Interventions

CAPA-Fresh PROCEDURE

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.

CAPA-Fresh

CAPA-Freeze-only PROCEDURE

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.

CAPA-Freeze-only

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Oocyte donation cycles
• Pre-implantation genetic diagnosis (PGD) cycles

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 33825118 DERIVED

Study Officials

• Lan N Vuong, MD, PhD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: March 6, 2020
• Primary Completion: August 18, 2020
• Study Completion: December 15, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)