Efficacy Study of Segmentation of PGD Treatment

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

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

Study Overview

• Status: Unknown
• Conditions: Live Birth; Clinical Pregnancy
• Intervention / Treatment: Procedure: elective cryopreservation of available embryos after PGD; Procedure: PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD

• Study Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Centre for Reproductive Medicine UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: freeze all embryos following PGD; no fresh embryo transfer; elective cryopreservation of all embryos after PGD	Procedure: elective cryopreservation of available embryos after PGD; no elective fresh embryo transfer; freeze all; Other Names: freeze all embryos
Active Comparator: elective fresh embryo transfer	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; Other Names: fresh ET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative live birth rate of a single PGD treatment	cumulative LBR	1 year

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: pregnancy; cryopreservation; preimplantation genetic diagnosis
• Other Study ID Numbers: B.U.N. 143201420647