NCT02265614

Brief Summary

This project intends to use preimplantation genetic screening (PGS) with the microarray technique to determine the chromosome composition of fertilized eggs, so that only chromosomally normal embryos are transferred during IVF. The purpose is to increase the probability of pregnancy and childbirth among couples with a history of repeated unsuccessful IVF attempts.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

1.8 years

First QC Date

October 10, 2014

Last Update Submit

October 17, 2014

Conditions

Infertility

Keywords

PGSblastocysthumanIVFvitrificationsingle embryo transfer

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy per randomized patient

    2 years

Secondary Outcomes (2)

  • cumulative pregnancy rate,

    3 years

  • miscarriage rate during the first 18 weeks of pregnancy

    2 years

Study Arms (2)

PGS

EXPERIMENTAL

blastocyst biopsy and chromosomal analysis

Genetic: PGS

control

NO INTERVENTION

regular IVF

Interventions

PGSGENETIC
PGS

Eligibility Criteria

Age25 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Couples who meet the criteria for IVF treatment and who have a history of at least three previous IVF cycles including embryo transfer without delivery.
  • The woman may be a maximum of 39 years old when the study is carried out and must have a normal-good ovarian reserve (at least 12 antral follicles).
  • Her partner must be able to provide a semen sample containing live sperm.
  • Women included in the study will not participate in any other research project.

You may not qualify if:

  • Myoma, or other uterine lesions judged to affect implantation.
  • Nonspecific cysts that are not considered to be functional.
  • Endometrium \>3 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertilitetscentrum AB

Gothenburg, 40229, Sweden

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 16, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2016

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

SE(1)