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Active, not recruitingNCT04621773Updated Nov 9, 2020

Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss

An observational study in Recurrent Pregnancy Loss and Preimplantation Genetic Screening, sponsored by Peking University Third Hospital. Active, not recruiting at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-11-09.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years 1 month ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
20 Years to 45 Years
Sex
Female
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Recurrent Pregnancy Loss
  • Preimplantation Genetic Screening

Keywords

  • Unexplained Recurrent Pregnancy Loss
  • Preimplantation Genetic Screening
  • spontaneous pregnancy
03

In context

Abortion, Spontaneous

320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 140 observational studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients who seek treatment in our Recurrent Pregnancy Loss clinic.

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

Exclusion Criteria:

  • anatomic abnormality of the reproductive system; endocrine metabolic disease; autoimmune related disease; chromosomal abnormalities; hydrosalpinx; cervical insufficiency.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • PGS(Preimplantation Genetic Screening)

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

    Procedure: Preimplantation Genetic Screening(exposure)

  • SP(spontaneous pregnancy )

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

Interventions

  • ProcedurePreimplantation 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).

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What researchers measure

Primary outcomes

  1. Live birth rate

    the rate of the birth of a living fetus

    Time frame: 2 years of following up

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Study locations

1 site
  • Center of Reproductive Medicine, Peking University Third Hospital
    Beijing, Haidian 100191, China
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References and documents

Publications

  • 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. PubMed 27278003 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04621773
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Nov 9, 2020
Start date
Sep 1, 2020
Primary completion
Sep 1, 2023 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Nov 9, 2020

Study contacts

Rong Li, M.D.
study chair · Center of Reproductive Medicine, Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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