Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
252 participants
INTERVENTIONAL
2014-05-31
2016-01-31
Brief Summary
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Experimental questions
1. 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?
2. 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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freeze all embryos following PGD
no fresh embryo transfer; elective cryopreservation of all embryos after PGD
elective cryopreservation of available embryos after PGD
no elective fresh embryo transfer; freeze all
elective fresh embryo transfer
PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
Interventions
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elective cryopreservation of available embryos after PGD
no elective fresh embryo transfer; freeze all
PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion 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
20 Years
40 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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VERPOEST WILLEM
professor dr
Locations
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Centre for Reproductive Medicine UZ Brussel
Jette, Brussels Capital, Belgium
Countries
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Central Contacts
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WILLEM MJA VERPOEST, MD PHD
Role: CONTACT
Facility Contacts
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WILLEM MJA VERPOEST, MD PHD
Role: primary
References
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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.
Other Identifiers
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B.U.N. 143201420647
Identifier Type: -
Identifier Source: org_study_id
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