SubfertilityNCT04196036
Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos
A study testing Day of vitrification in people with Subfertility, run by Sophie Debrock at 1 site in Belgium.
Trial summary
This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Day of vitrification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
- who are older than 18 and less than 38 years old
- who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels
Who cannot join
- treatment with donor oocytes or donor embryos
- patients planned for Pre-implantation Genetic Diagnosis (PGD)
- Patients with BMI>30
- patients with endometriosis grade III-IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cumulative Pregnancy Rates and Direct Healthcare Cost Analysis of Two Different Strategies: Fresh Cleavage-stage Embryo Transfer (ET) on Day 3 With Vitrification of Supernumerary Embryos on Day 3 Versus Day 5
This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.
The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.
- Conditions
- Subfertility
- Being tested
- Day of vitrification
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day of vitrificationProcedure or surgery
Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5
| Study group | Role | What they receive |
|---|---|---|
| Day 3 vitrification | Active comparator | Day of vitrification of supernumerary embryos is day 3 Receives: Procedure: Day of vitrification |
| Day 5 vitrification | Active comparator | Day of vitrification of supernumerary embryos is day5 Receives: Procedure: Day of vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative pregnancy rate
The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)
Measured: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
Secondary outcomes (1)
cost analysis
cost analysis of day 3 and day 5 vitrification strategy
Measured: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start15 Jan 2018
- Primary completion31 Jul 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophie Debrock
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sophie Debrock, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196036
- Sponsor's protocol ID
- S60974
- Status last verified
- Mar 2022
- First submitted
- 15 Jan 2018
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mengels A, Van Muylder A, Peeraer K, Luyten J, Laenen A, Spiessens C, Debrock S. Cumulative pregnancy rates of two strategies: Day 3 fresh embryo transfer followed by Day 3 or Day 5/6 vitrification and embryo transfer: a randomized controlled trial. Hum Reprod. 2024 Jan 5;39(1):62-73. doi: 10.1093/humrep/dead222.
PubMed 37886820
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative Pregnancy Rates and Direct Healthcare Cost Analysis of Two Different Strategies: Fresh Cleavage-stage Embryo Transfer (ET) on Day 3 With Vitrification of Supernumerary Embryos on Day 3 Versus Day 5
- ClinicalTrials.gov ID
- NCT04196036
- Acronym / sponsor ID
- S60974
- Conditions
- Subfertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sophie DebrockUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.
The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day 3 vitrification | Active comparator | Procedure: Day of vitrificationDay of vitrification of supernumerary embryos is day 3 |
| Day 5 vitrification | Active comparator | Procedure: Day of vitrificationDay of vitrification of supernumerary embryos is day5 |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
- who are older than 18 and less than 38 years old
- who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels
Key exclusion criteria (4 listed)
- treatment with donor oocytes or donor embryos
- patients planned for Pre-implantation Genetic Diagnosis (PGD)
- Patients with BMI>30
- patients with endometriosis grade III-IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day of vitrificationSupernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5 | Procedure or surgery | Day 3 vitrification, Day 5 vitrification |
Primary outcome
cumulative pregnancy rate
Time frame: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)
1 secondary outcome
cost analysis
Time frame: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 37886820Mengels A, Van Muylder A, Peeraer K, Luyten J, Laenen A, Spiessens C, Debrock S. Cumulative pregnancy rates of two strategies: Day 3 fresh embryo transfer followed by Day 3 or Day 5/6 vitrification and embryo transfer: a randomized controlled trial. Hum Reprod. 2024 Jan 5;39(1):62-73. doi: 10.1093/humrep/dead222.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day of vitrification in people with Subfertility, run by Sophie Debrock at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative pregnancy rate (time frame: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.