Clinical PregnancyNCT02133950
Efficacy Study of Segmentation of PGD Treatment
A study testing elective cryopreservation of available embryos after PGD and PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD in people with Clinical Pregnancy and Live Birth, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
A single centre observational study into the segmentation of preimplantation genetic diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation of all genetically transferable embryos after PGD, compared to fresh embryo transfer cumulative with frozen embryo transfer of genetically… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Clinical Pregnancy, Live Birth
- What is being tested?
- elective cryopreservation of available embryos after PGD and PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteBelgium
- Study dates
- May 2014to Jan 2016
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1st, 2nd or 3rd cycle of PGD in which embryo transfer was performed
- Indications for PGD: monogenic indications and X-linked disorders with a 25-50% risk of transmission and that are not associated with reduced ovarian response
- Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
Who cannot join
- POLYCYSTIC OVARIAN SYNDROME (Rotterdam criteria *)
- At least two of the following three features: (i) Oligo- and/or anovulation (ii) Clinical and/or biochemical signs of hyperandrogenism (iii) Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumours, Cushing's syndrome)
- Poor responders (Bologna criteria **)
- * At least two of the following three features: (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (POR); (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles, or anti-Mullerian hormone (AMH) 0.5-1.1 ng/ml).
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
- anticipated high response: AMH >5.0 ng/ml or AFC >20
- Endometriosis ≥ grade 3
- Age > 40 years and 364 days
Trial locations and contacts
1 site in 1 country.
WILLEM MJA VERPOEST, MD PHD contact
Belgium1 site
Centre for Reproductive Medicine UZ Brussel
Jette, Brussels Capital, 1090
WILLEM MJA VERPOEST, MD PHD, +3224776699
About this study
Official title: A Single Centre Randomised Controlled Study Into the Segmentation of Preimplantation Genetic Diagnosis (PGD) Treatment by Comparing Cumulative Pregnancy Rates Following Cryopreservation of All Genetically Transferable Embryos After PGD, Compared to Fresh Embryo Transfer Cumulative With Frozen Embryo Transfer of Genetically Transferable Embryos.
A single centre observational study into the segmentation of preimplantation genetic diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation of all genetically transferable embryos after PGD, compared to fresh embryo transfer cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of the study is to assess the feasibility and effectiveness of segmentation in terms of pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD cycles.
Experimental questions
Read more
- Is the cumulative live birth rate rate of a single PGD treatment when all genetically transferable embryos are cryopreserved by vitrification prior to consecutive in utero transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer cumulative with transfer of supernumerary cryopreserved embryos?
- Does the technique of segmentation allow better planning of DNA amplification and genetic analysis?
Design The proposed design is a pragmatic, prospective randomised controlled trial
- Conditions
- Clinical Pregnancy, Live Birth
- Being tested
- elective cryopreservation of available embryos after PGD, PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
- Keywords
- preimplantation genetic diagnosis, cryopreservation, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective cryopreservation of available embryos after PGDProcedure or surgery
Also called freeze all embryos
no elective fresh embryo transfer; freeze all
PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGDProcedure or surgery
Also called fresh ET
PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
| Study group | Role | What they receive |
|---|---|---|
| freeze all embryos following PGD | Experimental | no fresh embryo transfer; elective cryopreservation of all embryos after PGD Receives: Procedure: elective cryopreservation of available embryos after PGD |
| elective fresh embryo transfer | Active comparator | Not described Receives: Procedure: PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative live birth rate of a single PGD treatment
cumulative LBR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
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 Clinical PregnancyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VERPOEST WILLEM, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133950
- Sponsor's protocol ID
- B.U.N. 143201420647
- Status last verified
- May 2014
- First submitted
- 6 May 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33539543
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Randomised Controlled Study Into the Segmentation of Preimplantation Genetic Diagnosis (PGD) Treatment by Comparing Cumulative Pregnancy Rates Following Cryopreservation of All Genetically Transferable Embryos After PGD, Compared to Fresh Embryo Transfer Cumulative With Frozen Embryo Transfer of Genetically Transferable Embryos.
- ClinicalTrials.gov ID
- NCT02133950
- Acronym / sponsor ID
- B.U.N. 143201420647
- Conditions
- Clinical Pregnancy, Live Birth
- Keywords
- preimplantation genetic diagnosis, cryopreservation, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 8 May 2014 (estimated)
- 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.
A single centre observational study into the segmentation of preimplantation genetic diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation of all genetically transferable embryos after PGD, compared to fresh embryo transfer cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of the study is to assess the feasibility and effectiveness of segmentation in terms of pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD cycles.
Experimental questions
- Is the cumulative live birth rate rate of a single PGD treatment when all genetically transferable embryos are cryopreserved by vitrification prior to consecutive in utero transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer cumulative with transfer of supernumerary cryopreserved embryos?
- Does the technique of segmentation allow better planning of DNA amplification and genetic analysis?
Design The proposed design is a pragmatic, prospective randomised controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| freeze all embryos following PGD | Experimental | Procedure: elective cryopreservation of available embryos after PGDno fresh embryo transfer; elective cryopreservation of all embryos after PGD |
| elective fresh embryo transfer | Active comparator | Procedure: PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1st, 2nd or 3rd cycle of PGD in which embryo transfer was performed
- Indications for PGD: monogenic indications and X-linked disorders with a 25-50% risk of transmission and that are not associated with reduced ovarian response
- Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
Key exclusion criteria (8 listed)
- POLYCYSTIC OVARIAN SYNDROME (Rotterdam criteria *)
- Poor responders (Bologna criteria **)
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
- anticipated high response: AMH >5.0 ng/ml or AFC >20
- Endometriosis ≥ grade 3
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 |
|---|---|---|
| elective cryopreservation of available embryos after PGDAlso: freeze all embryosno elective fresh embryo transfer; freeze all | Procedure or surgery | freeze all embryos following PGD |
| PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGDAlso: fresh ETPGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD | Procedure or surgery | elective fresh embryo transfer |
Primary outcome
cumulative live birth rate of a single PGD treatment
Time frame: 1 year
cumulative LBR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 33539543Zaat 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.
Related trials for Clinical Pregnancy
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
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.
WILLEM MJA VERPOEST, MD PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elective cryopreservation of available embryos after PGD and PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD in people with Clinical Pregnancy and Live Birth, run by Universitair Ziekenhuis Brussel 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 May 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WILLEM MJA VERPOEST, MD PHD (+3224776699), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative live birth rate of a single PGD treatment (time frame: 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 NCT02133950, 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 8 May 2014.