NCT04643938

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

Same day

First QC Date

November 3, 2020

Last Update Submit

November 20, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • Baseline characteristics

    Age

    January 2012 to December 2016

  • Baseline characteristics

    basal sex hormone

    January 2012 to December 2016

  • Baseline characteristics

    the number of abortion

    January 2012 to December 2016

  • laboratory outcomes of patients

    Oocyte count

    January 2012 to December 2016

  • laboratory outcomes of patients

    Number of blastocysts

    January 2012 to December 2016

  • clinical outcoms

    normal karyotype blastocyst rate

    January 2012 to January 2020

  • clinical outcoms

    live birth rate

    January 2012 to January 2020

  • clinical outcoms

    Cumulative pregnancy rate

    January 2012 to January 2020

Study Arms (3)

Two spontaneous abortions

No intervention

three spontaneous abortions

No intervention

Four or more spontaneous abortions

No intervention

Eligibility Criteria

Age20 Years - 46 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBoth biological and social sexes are female
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Reproductive Medicine, Peking University Third Hospital

Beijing, Haidian, 100191, China

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Haiyan Wang, M.D.

    Center of Reproductive Medicine, Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 25, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations