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Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss

NCT ID: NCT04621773

Last Updated: 2020-11-09

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

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-09-01

Brief Summary

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STUDY AIM: to study the pregnancy outcomes and offspring development of patient with Unexplained Recurrent Pregnancy Loss Treated by PGS and spontaneous pregnancy, and to compare the health economic indicators and patient satisfaction of the two modes of pregnancy, so as to better guide the clinical treatment.

Detailed Description

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400 patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy are intended to be enrolled. They are going to divided into two groups: PGS(preimplantation genetic screening) group and SP(spontaneous pregnancy) group. The pregnancy outcomes and offspring development of those patients will be followed up by our investigators.

Conditions

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Recurrent Pregnancy Loss Preimplantation Genetic Screening

Keywords

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Unexplained Recurrent Pregnancy Loss Preimplantation Genetic Screening spontaneous pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PGS(Preimplantation Genetic Screening)

patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure

Preimplantation Genetic Screening(exposure)

Intervention Type PROCEDURE

Preimplantation genetic screening (PGS) was developed in the late 1980s as an alternative to prenatal diagnosis for couples at risk of transmitting a genetic or chromosomal abnormality to their children. In embryos created through in vitro fertilisation (IVF), cells are biopsied and analysed using genetic tests such as polymerase chain reaction and fluorescent in situ hybridisation (FISH).

SP(spontaneous pregnancy )

patients with two times or more unexplained pregnancy loss, who wants to be pregnant via spontaneous pregnancy.

No interventions assigned to this group

Interventions

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Preimplantation Genetic Screening(exposure)

Preimplantation genetic screening (PGS) was developed in the late 1980s as an alternative to prenatal diagnosis for couples at risk of transmitting a genetic or chromosomal abnormality to their children. In embryos created through in vitro fertilisation (IVF), cells are biopsied and analysed using genetic tests such as polymerase chain reaction and fluorescent in situ hybridisation (FISH).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with two times or more unexplained pregnancy loss(less than 24 weeks of gestational age, biochemical pregnancy excluded), who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy.

Exclusion Criteria

* anatomic abnormality of the reproductive system; endocrine metabolic disease; autoimmune related disease; chromosomal abnormalities; hydrosalpinx; cervical insufficiency.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rong Li, M.D.

Role: STUDY_CHAIR

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

References

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Murugappan G, Shahine LK, Perfetto CO, Hickok LR, Lathi RB. Intent to treat analysis of in vitro fertilization and preimplantation genetic screening versus expectant management in patients with recurrent pregnancy loss. Hum Reprod. 2016 Aug;31(8):1668-74. doi: 10.1093/humrep/dew135. Epub 2016 Jun 7.

Reference Type BACKGROUND
PMID: 27278003 (View on PubMed)

Other Identifiers

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2019SZ-087

Identifier Type: -

Identifier Source: org_study_id