NCT03405701

Brief Summary

In vitro maturation (IVM) is postulated to be an alternative to conventional in vitro fertilization (IVF) to avoid ovarian hyperstimulation syndrome. This has particular potential in women with Polycystic Ovarian Syndrome (PCOS), who are at increased risk for the ovarian hyperstimulation syndrome. However, no randomized controlled trials on the comparison of IVM and conventional IVF in women with PCOS have been reported with respect to pregnancy rate and hyper-stimulation. Investigators aim to compare the effectiveness and safety of IVM with controlled ovarian hyperstimulation/IVF in women with high antral follicle count.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
546

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
Last Updated

December 4, 2019

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

December 16, 2017

Last Update Submit

December 3, 2019

Conditions

PCOSIVFIVM

Outcome Measures

Primary Outcomes (1)

  • 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 (twins will be a single count). To allow assessment of the timing of live birth, the rate of ongoing pregnancy at 12 weeks will be used in calculations, conditional on the fact that this ongoing pregnancy results in live birth.

    12 weeks of gestation

Secondary Outcomes (9)

  • 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

  • Ongoing pregnancy

    at 10 weeks or beyond after the embryo placement after the completion of the first transfer

  • Implantation rate

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

  • Number of top quality embryos

    3 days after oocytes pick-up day in IVF or 5 days in IVM

  • +4 more secondary outcomes

Other Outcomes (58)

  • Ovarian hyperstimulation syndrome (OHSS)

    at 03 days after oocytes pick-up and 14 days after embryo transfer

  • Ectopic pregnancy

    at 12 weeks of gestation after the completion of the first transfer

  • Ectopic pregnancy

    at 6 months after randomisation

  • +55 more other outcomes

Study Arms (2)

IVM (in vitro maturation)

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: IVM

IVF (in vitro fertilization)

ACTIVE COMPARATOR

Undergoing controlled ovarian hyperstimulation for in vitro Fertilization (IVF) with recombinant FSH (Menopur, Ferring) in GnRH antagonist protocol, treatment monitoring using ultrasound scans and blood tests. GnRH agonist triggering will be used for final oocytes maturation. 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: IVF

Interventions

IVMPROCEDURE

Patients in IVM group will receive FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and the 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.

IVM (in vitro maturation)
IVFPROCEDURE

Patients in IVF arm will undergo controlled ovarian hyperstimulation with recombinant FSH (Menopur, Ferring) in GnRH antagonist protocol, treatment monitoring using ultrasound scans and blood tests. GnRH agonist will be used for final oocytes maturation. 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.

IVF (in vitro fertilization)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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 all embryos frozen on day 3
  • Agree to have ≤ 2 embryos transferred in a subsequent frozen transfer
  • Not participating in another IVF study at the same time

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Location

Related Publications (3)

  • Saucedo-Cuevas L, Ma MPQ, Le AH, Akin N, Pham TD, Ho TM, Pita G, Gonzalez-Neira A, De Vos M, Smitz J, Anckaert E, Vuong LN. Epigenetic variation in neonatal tissues in infants conceived using capacitation-in vitro maturation vs. in vitro fertilization. Fertil Steril. 2024 Mar;121(3):506-518. doi: 10.1016/j.fertnstert.2023.11.040. Epub 2023 Dec 3.

    PMID: 38052376DERIVED

  • Vuong LN, Ho VNA, Ho TM, Dang VQ, Phung TH, Giang NH, Le AH, Pham TD, Wang R, Smitz J, Gilchrist RB, Norman RJ, Mol BW. In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial. Hum Reprod. 2020 Nov 1;35(11):2537-2547. doi: 10.1093/humrep/deaa240.

    PMID: 32974672DERIVED

  • Vuong LN, Ho VNA, Ho TM, Dang VQ, Phung TH, Giang NH, Le AH, Pham TD, Wang R, Norman RJ, Smitz J, Gilchrist RB, Mol BW. Effectiveness and safety of in vitro maturation of oocytes versus in vitro fertilisation in women with high antral follicle count: study protocol for a randomised controlled trial. BMJ Open. 2018 Dec 9;8(12):e023413. doi: 10.1136/bmjopen-2018-023413.

    PMID: 30530584DERIVED

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

December 16, 2017

First Posted

January 23, 2018

Study Start

January 25, 2018

Primary Completion

November 30, 2019

Study Completion

December 3, 2019

Last Updated

December 4, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)