Implantation Enhancement by Elective Cryopreservation of All Viable Embryos
ICE
Elective Blastocyst Vitrification for Endometrial Receptivity Enhancement in High-responder Patients Undergoing in Vitro Fertilisation/Intracytoplasmatic Sperm Injection (IVF/ICSI)
2 other identifiers
interventional
212
1 country
1
Brief Summary
A randomised controlled open-label clinical trial to compare the clinical pregnancy rates between fresh embryo transfer and elective all-embryo vitrification with thawing and transfer in a subsequent cycle in high-responders
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedMarch 9, 2018
March 1, 2018
2.8 years
May 16, 2014
March 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rates
Pregnancy visible under transvaginal pelvic ultrasound
7 weeks
Secondary Outcomes (1)
Ovarian hyperstimulation syndrome incidence
8 weeks
Study Arms (2)
Control
ACTIVE COMPARATORIn the control group, following oocyte retrieval, intensified luteal phase support for fresh embryo transfer (with Pregnyl®, Utrogestan® and Progynova®) will be performed. Fresh ET in the uterine cavity will be performed on the 5th day of embryo development at blastocyst stage under ultrasound guidance whenever possible.
Intervention
EXPERIMENTALElective vitrification with subsequent-cycle embryo thawing/transfer (CryoBioSystem®) will be performed. Hence, no luteal phase support will be provided immediately after oocyte retrieval. Instead, patients will wait for a subsequent cycle before starting exogenous hormone therapy for endometrial preparation. On the day of embryo transfer, blastocyst(s) will be warmed one by one until one or two blastocysts are suitable for transfer. ET to the uterine cavity will be performed under ultrasound guidance whenever possible.
Interventions
The vitrification process will be performed under the same conditions of all other vitrification procedures usually performed in our centre. In summary, vitrification will be accomplished using closed high security straws (CryoBioSystem®) in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®). In the meantime, patients will wait for a subsequent cycle before starting exogenous hormone therapy for endometrial preparation.
A single administration of 1500 IU of exogenous hCG (Pregnyl®) 1 hour after oocyte retrieval followed by daily vaginally-administered progesterone 200 mg tid (Utrogestan®) and oestradiol valerate 2 mg bid (Progynova®).
CryoBioSystem® in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®) closed in high security straws
Eligibility Criteria
You may qualify if:
- First or second IVF/ICSI cycle
- High response to ovarian stimulation (defined as presence of ≥18 follicles of ≥11 mm on the day of GnRH triggering)
- GnRH antagonist down-regulation
- Signed informed consent
- Patients can be included only once in the trial
- Planned replacement of 1 or 2 blastocysts
You may not qualify if:
- Other known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis)
- Oocyte/embryos donation acceptors
- Embryos planned to undergo preimplantation genetic diagnosis/screening
- Body mass index ≥35 or ≤18
- Women who have previously enrolled in the trial
- Those unable to comprehend the investigational nature of the proposed study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitair Ziekenhuis Brussel
Brussels, Lisboa, 1600-548, Belgium
Related Publications (2)
Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.
PMID: 33539543DERIVEDSantos-Ribeiro S, Mackens S, Popovic-Todorovic B, Racca A, Polyzos NP, Van Landuyt L, Drakopoulos P, de Vos M, Tournaye H, Blockeel C. The freeze-all strategy versus agonist triggering with low-dose hCG for luteal phase support in IVF/ICSI for high responders: a randomized controlled trial. Hum Reprod. 2020 Dec 1;35(12):2808-2818. doi: 10.1093/humrep/deaa226.
PMID: 32964939DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Santos-Ribeiro, MD
Universitair Ziekenhuis Brussel
- PRINCIPAL INVESTIGATOR
Christophe Blockeel, PhD
Universitair Ziekenhuis Brussel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
May 16, 2014
First Posted
May 28, 2014
Study Start
May 1, 2014
Primary Completion
February 28, 2017
Study Completion
February 28, 2017
Last Updated
March 9, 2018
Record last verified: 2018-03