Trial Outcomes & Findings for PGT-A Versus Blastocyst Morphology Selection (NCT NCT03095053)

Results Overview

A live birth cycle was defined as a cycle with a delivery after 20 weeks of gestation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

302 participants

Primary outcome timeframe

>20 weeks gestation

Results posted on

2019-06-17

Participant Flow

The patient population of the RCT consisted of patients who underwent autologous blastocyst freeze-all IVF cycles between March and October 2016, at a private IVF center

Excluded (N =82) Patients with no blastocyst Patients with \<2 blastocysts Patients with only one 2BB blastocyst

Participant milestones

Participant milestones
Measure	PGT-A Group comprehensive chromosome screening comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts. Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA).	Morphology Group morphological assessment of blastocyst by light microscope
Overall Study STARTED	109	111
Overall Study COMPLETED	80	111
Overall Study NOT COMPLETED	29	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PGT-A Group n=109 Participants comprehensive chromosome screening comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts. Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA).	Morphology Group n=111 Participants morphological assessment of blastocyst by light microscope	Total n=220 Participants Total of all reporting groups
Age, Continuous	28.5 years STANDARD_DEVIATION 3.71 • n=109 Participants	28.3 years STANDARD_DEVIATION 3.24 • n=111 Participants	28.4 years STANDARD_DEVIATION 3.48 • n=220 Participants
Sex/Gender, Customized	109 Participants n=109 Participants	111 Participants n=111 Participants	220 Participants n=220 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body mass index	25.3 kg/m^2" STANDARD_DEVIATION 4.11 • n=109 Participants	25.1 kg/m^2" STANDARD_DEVIATION 4.49 • n=111 Participants	25.2 kg/m^2" STANDARD_DEVIATION 4.3 • n=220 Participants
Antral follicle count	21.9 number of antral follicles STANDARD_DEVIATION 14.16 • n=109 Participants	24.2 number of antral follicles STANDARD_DEVIATION 16.28 • n=111 Participants	23.1 number of antral follicles STANDARD_DEVIATION 15.27 • n=220 Participants
Infertility duration	3.9 years STANDARD_DEVIATION 2.64 • n=109 Participants	4.4 years STANDARD_DEVIATION 3.10 • n=111 Participants	4.2 years STANDARD_DEVIATION 2.89 • n=220 Participants

PRIMARY outcome

Timeframe: >20 weeks gestation

Population: The live birth rates in the study trial groups

A live birth cycle was defined as a cycle with a delivery after 20 weeks of gestation.

Outcome measures

Outcome measures
Measure	Euploid Subgroup n=80 Participants comprehensive chromosome screening comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts. Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA).	Morphology Group n=111 Participants morphological assessment of blastocyst by light microscope
The Percentage of Patients With a Live Birth	45 Participants	65 Participants

SECONDARY outcome

Timeframe: >5 weeks of gestation

Population: The clinical pregnancy rates in the study trial groups

A clinical pregnancy was defined as a cycle with a fetal sac observed on ultrasound after 5 weeks of gestation

Outcome measures

Outcome measures
Measure	Euploid Subgroup n=80 Participants comprehensive chromosome screening comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts. Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA).	Morphology Group n=111 Participants morphological assessment of blastocyst by light microscope
The Percentage of Patients With a Clinical Pregnancy	49 Participants	76 Participants

SECONDARY outcome

Timeframe: <20 weeks

Population: The miscarriage rates in the study trial groups

A miscarriage was defined as the loss of a clinical pregnancy before 20 weeks of gestation.

Outcome measures

Outcome measures
Measure	Euploid Subgroup n=49 Participants comprehensive chromosome screening comprehensive chromosome screening: Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts. Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA).	Morphology Group n=76 Participants morphological assessment of blastocyst by light microscope
The Percentage of Pregnancies That Miscarried	3 Participants	11 Participants

Adverse Events

PGT-A Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morphology Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin Coetzee

Antalya IVF

Phone: 090 530 764 3135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place