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PGT-A in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage

NCT ID: NCT04643938

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-02-01

Brief Summary

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uRM patients selected PGT-A from 2012 to 2016 were included in this study. Their clinical outcomes were prospectively observed and analyzed to explore the factor influenced the outcomes.

Detailed Description

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This prospective observational study enrolled all women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016. If a couple underwent multiple stimulation cycles during the research period, only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A. All included stimulation cycles involved intracytoplasmic sperm injection insemination. After successfully fertilized embryos formed blastocysts on Day 5-7, trophoblasts were biopsied to determine embryonic karyotypes. The blastocysts with normal/balanced test results were cryopreserved, whereas abnormal blastocysts were discarded after notifying the patients. All normal blastocysts from a patient were thawed and transferred singly, and the outcomes of all subsequent frozen-thawed embryo transfer cycles were followed-up until January 2020.

Clinical outcomes included the blastocyst formation rate, the proportion of blastocysts with normal karyotypes, and the clinical pregnancy, live birth, and cumulative live birth rates. The factors that affected these clinical outcomes were analyzed to predict outcomes and guide treatment in women with uRM.

Conditions

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Recurrent Early Pregnancy Loss

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Two spontaneous abortions

No intervention

No interventions assigned to this group

three spontaneous abortions

No intervention

No interventions assigned to this group

Four or more spontaneous abortions

No intervention

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016.Only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A.

Exclusion Criteria

Couples with parental chromosomal abnormalities were excluded, as were women with anatomical abnormalities of the uterus, autoimmune diseases, and endocrine abnormalities.
Minimum Eligible Age

20 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Haiyan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haiyan Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Center of Reproductive Medicine, Peking University Third Hospital

Locations

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Center of Reproductive Medicine, Peking University Third Hospital

Beijing, Haidian, China

Site Status

Countries

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China

Other Identifiers

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2019SZ-076

Identifier Type: -

Identifier Source: org_study_id