Trial Outcomes & Findings for Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer (NCT NCT01194531)

Results Overview

Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

59 participants

Primary outcome timeframe

Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.

Results posted on

2014-11-25

Participant milestones
Measure	CONTROL Arm Subjects assigned to this arm of the study will receive no PGS testing.	TEST Arm Subjects assigned to this arm of the study will receive PGS testing. 24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)
Overall Study STARTED	29	30
Overall Study COMPLETED	24	27
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal
Measure	CONTROL Arm Subjects assigned to this arm of the study will receive no PGS testing.	TEST Arm Subjects assigned to this arm of the study will receive PGS testing. 24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	4	1
Overall Study Physician Decision	0	2

Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer

Baseline characteristics by cohort
Measure	CONTROL Arm n=29 Participants Subjects assigned to this arm of the study will receive no PGS testing.	TEST Arm n=30 Participants Subjects assigned to this arm of the study will receive PGS testing. 24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)	Total n=59 Participants Total of all reporting groups
Age, Continuous	38 years n=5 Participants	37.3 years n=7 Participants	37.7 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

Timeframe: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.

Population: Patients who reached embryo transfer were included in this analysis.

Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.

Outcome measures
Measure	CONTROL Arm n=22 Participants Subjects assigned to this arm of the study will receive no PGS testing.	TEST Arm n=21 Participants Subjects assigned to this arm of the study will receive PGS testing. 24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)
Implantation Rate	24 percentage of implantation per group	35 percentage of implantation per group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Natera (formerly Gene Security Network)

Phone: 650-249-9090

Principal investigator is a sponsor employee Each PI signed an agreement that all data, analyses, information and materials prepared or derived as a direct result of the Study are required to be provided to the sponsor and in accordance with the Protocol, whether preliminary or final (the "Study Results") shall be property of the sponsor. Site may utilize the Study Results for patient care and for it's own internal education purposes.
Publication restrictions are in place

Restriction type: OTHER