NCT02133950

Brief 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 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. 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. 2.Does the technique of segmentation allow better planning of DNA amplification and genetic analysis?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

May 6, 2014

Last Update Submit

May 6, 2014

Conditions

Clinical PregnancyLive Birth

Keywords

preimplantation genetic diagnosiscryopreservationpregnancy

Outcome Measures

Primary Outcomes (1)

  • cumulative live birth rate of a single PGD treatment

    cumulative LBR

    1 year

Study Arms (2)

freeze all embryos following PGD

EXPERIMENTAL

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

Procedure: elective cryopreservation of available embryos after PGD

elective fresh embryo transfer

ACTIVE COMPARATOR
Procedure: PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD

Interventions

elective cryopreservation of available embryos after PGDPROCEDURE

no elective fresh embryo transfer; freeze all

Also known as: freeze all embryos
freeze all embryos following PGD
PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGDPROCEDURE

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

Also known as: fresh ET
elective fresh embryo transfer

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • st, 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.

You may not qualify if:

  • POLYCYSTIC OVARIAN SYNDROME (Rotterdam criteria \*)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Reproductive Medicine UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

  • 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: 33539543DERIVED

MeSH Terms

Interventions

Prostaglandins D

Intervention Hierarchy (Ancestors)

ProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

WILLEM MJA VERPOEST, MD PHD

CONTACT

+3224776699

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
professor dr

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

BE(1)