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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02265614
Date of registration: 10/10/2014
Prospective Registration: No
Primary sponsor: IVF Research Sweden
Public title: PGS Using Microarray in IVF Patients With Repeated Implantation Failure
Scientific title: Preimplantation Genetic Screening (PGS) Using Microarray Technique: Method to Select the Embryo With the Greatest Chance for Successful Implantation During in Vitro Fertilization in Couples With a History of Unsuccessful IVF Attempts
Date of first enrolment: August 2014
Target sample size: 130
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT02265614
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Sweden
Contacts
Name:     Torbjorn Hillensjö, MD
Address: 
Telephone: +46317104600
Email: torbjorn.hillensjo@fertilitetscentrum.se
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Myoma, or other uterine lesions judged to affect implantation.

- Nonspecific cysts that are not considered to be functional.

- Endometrium >3 cm.



Age minimum: 25 Years
Age maximum: 39 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Infertility
Intervention(s)
Genetic: PGS
Primary Outcome(s)
ongoing pregnancy per randomized patient [Time Frame: 2 years]
Secondary Outcome(s)
cumulative pregnancy rate, [Time Frame: 3 years]
miscarriage rate during the first 18 weeks of pregnancy [Time Frame: 2 years]
Secondary ID(s)
IVFResearch
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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