A Randomized Double Blind Controlled Trial of Non-invasive Preimplantation Genetic Testing for Aneuploidy in Women With Recurrent Pregnancy Loss

niPGTAinRPL

Objectives: 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 women with recurrent pregnancy loss (RPL) undergoing in vitro fertilization (IVF). Hypothesis to be tested: The embryo selection based on morphology and niPGT-A results in a lower miscarriage rate and a higher live birth rate in IVF as compared with that based on morphology alone. Design and subjects: Randomized double-blind randomized controlled trial. Women with RPL undergoing IVF will be enrolled. Interventions: Spent culture medium (SCM) of each blastocyst will be frozen individually. They will be randomly allocated 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. Main outcome measures: The primary outcome is the miscarriage rate per the first embryo transfer. Data analysis: Comparison of quantitative variables will be performed using Student's t, while categorical variables will be compared using a Chi-square analysis. All statistical analyses will be performed with the intention to treat and per protocol, and a p-value \<0.05 will be considered statistically significant. Expected outcome results: The embryo selection based on morphology and niPGT-A results in a lower miscarriage rate and a higher live birth rate in IVF as compared with the control group based on morphology alone.

2023-07-01

2025-02-27

2026-02-27

Not yet recruiting

152

Inclusion Criteria: 1. Women aged less than 40 years at the time of ovarian stimulation and 2. \>=two spontaneous miscarriages in the first trimester 3. Unexplained recurrent pregnancy loss after standard investigation 4. At least one blastocyst available on day 5 or 6 after the retrieval. Exclusion Criteria: 1. Women undergoing PGT for monogenic diseases or structural rearrangement of chromosomes; 2. Use of donor oocytes; 3. Hydrosalpinx shown on pelvic scanning and not surgically treated 4. Uterine anomalies distorting the uterine cavity in three dimensional ultrasound 5. No usable blastocysts on day 5 or 6 after the retrieval

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "The embryologist will grade the morphology of blastocysts according to Gardner's criteria stated above and enter the grading of blastocysts into an online database, which will be managed by an IT technician. The laboratory staff in the PGT laboratory will enter the PGT result into a local database when the NIPGT results are available. The IT technician will collect the database from the PGT laboratory and enter it into the online software to compile the sequence of embryo transfer according to a pre-determined algorithm which depends on the day of blastocyst development (day 5 better than day 6), blastocyst morphology and niPGT-A result. The IT technician will issue the sequence of embryo transfer which does not contain information on the grading of the blastocyst and the NIPGT result to the embryologists in the IVF laboratory. Therefore, the subjects recruited, the clinicians and the embryologists will be blinded to the group allocation.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 152, 'type': 'ESTIMATED'}}

2023-07-03