RCT of niPGT for Aneuploidy and Morphology Compared With Morphology Alone in IVF

Not Applicable

Recruiting

• Conditions: Preimplantation Diagnosis
• Interventions: Genetic: Non-invasive Preimplantation genetic testing for aneuploidy status

• Registration Number: NCT04474522
• Lead Sponsor: The University of Hong Kong

Brief Summary

This study is to compare the efficacy in embryo selection based on morphology alone compared to morphology and non-invasive preimplantation genetic testing for aneuploidy (NIPGT-A) in infertile women undergoing in vitro fertilization (IVF). We supposed the embryo selection based on morphology and NIPGT-A results in a higher live birth rate and a lower miscarriage rate in IVF as compared with that based on morphology alone. Therefore we would like to conduct a double-blind randomized controlled trial.

Infertile women undergoing IVF will be enrolled. The spent culture medium (SCM) of each blastocyst will be frozen individually. They will be randomized into two groups: (1) the intervention group based on morphology and NIPGT-A and (2) the control group based on morphology alone. In the control group, blastocysts with the best quality morphology will be replaced first. In the intervention group, blastocysts with the best morphology and euploid result of SCM will be replaced first.The primary outcome is a live birth per the first embryo transfer. We would like to compare live birth rates and miscarriage rates between the two groups.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2021-07-01
• Primary Completion: 2023-05-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Women aged less than 43 years at the time of ovarian stimulation
• At least two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval

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Exclusion Criteria

• Less than two blastocysts suitable for freezing on day 5 or 6 after oocyte retrieval;
• Women undergoing PGT for monogenic diseases or structural rearrangement of chromosomes;
• Use of donor oocytes;
• Hydrosalpinx shown on pelvic scanning and not surgically treated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group using morphology and NIPGT-A	Non-invasive Preimplantation genetic testing for aneuploidy status	Both morphology and NIPGT-A result will be used to prioritize the sequence of embryo transfer in the intervention group.

Primary Outcome Measures

Name	Time	Method
Live birth	Number of live births beyond 22 weeks of gestation	Birth beyond 22 weeks of gestation per the first FET

Secondary Outcome Measures

Name	Time	Method
Apgar score	1 year	Pregnancy outcome
Time to pregnancy	1 year	between time of IVF and pregnancy
Ongoing pregnancy	10 weeks	Presence of a fetal pole with pulsation at 8-10 weeks of gestation
Miscarriage defined	Pregnancy loss up to 22 weeks	Clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.
Cumulative live birth rate	Number of pregnancies leading to live birth within 6 months of randomization	Number of pregnancies leading to live birth within 6 months of randomization
Positive urine pregnancy test	Positive urine pregnancy test 14 days after embryo transfer	Urine pregnancy test positive
Clinical pregnancy	6 weeks	Presence of intrauterine gestational sac on scanning at gestational week 6
Ectopic pregnancy	12 weeks	Pregnancy not in the uterus
Birth weight	1 year	Pregnancy outcome
Multiple pregnancy	more than one intrauterine sac at 6 weeks	presence of more than one intrauterine sac at 6 weeks of gestation

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology; 🇨🇳 Hong Kong, Hong Kong, China