Efficacy Study of Segmentation of PGD Treatment

Live Birth Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02133950
• Other study ID #: B.U.N. 143201420647
• Status: Not yet recruiting
• Phase: N/A
• First received: May 6, 2014
• Last updated: May 6, 2014
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2014
• Source: Universitair Ziekenhuis Brussel
• Contact: WILLEM MJA VERPOEST, MD PHD
• Phone: +3224776699
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 252
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Pregnancy
• Live Birth

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Belgium	Centre for Reproductive Medicine UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative live birth rate of a single PGD treatment	cumulative LBR	1 year	No