Efficacy Study of Segmentation of PGD Treatment

NCT ID: NCT02133950

Last Updated: 2014-05-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-01-31

Brief Summary

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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

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

Detailed Description

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Conditions

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Clinical Pregnancy Live Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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freeze all embryos following PGD

no fresh embryo transfer; elective cryopreservation of all embryos after PGD

Group Type EXPERIMENTAL

elective cryopreservation of available embryos after PGD

Intervention Type PROCEDURE

no elective fresh embryo transfer; freeze all

elective fresh embryo transfer

Group Type ACTIVE_COMPARATOR

PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Other Intervention Names

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freeze all embryos fresh ET

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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VERPOEST WILLEM

professor dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre for Reproductive Medicine UZ Brussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Central Contacts

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WILLEM MJA VERPOEST, MD PHD

Role: CONTACT

+3224776699

Facility Contacts

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WILLEM MJA VERPOEST, MD PHD

Role: primary

+3224776699

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.

Reference Type DERIVED
PMID: 33539543 (View on PubMed)

Other Identifiers

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B.U.N. 143201420647

Identifier Type: -

Identifier Source: org_study_id

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