Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss

NCT04621773 | Unknown

• 1 other identifier: 2019SZ-087
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Pregnancy Loss; Preimplantation Genetic Screening

Keywords

Unexplained Recurrent Pregnancy Loss; Preimplantation Genetic Screening; spontaneous pregnancy

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  the rate of the birth of a living fetus

  2 years of following up

Study Arms (2)

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

Preimplantation Genetic Screening(exposure) 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).

PGS(Preimplantation Genetic Screening)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients who seek treatment in our Recurrent Pregnancy Loss clinic.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Center of Reproductive Medicine, Peking University Third Hospital

Beijing, Haidian, 100191, China

Location

Related Publications (1)

• 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.

  PMID: 27278003 BACKGROUND

Study Officials

• Rong Li, M.D.

  Center of Reproductive Medicine, Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 9, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2025
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)