Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss

Recurrent Pregnancy Loss Clinical Trial

Official title:

Comparing the Live Birth Rate of Preimplantation Genetic Screening Versus Spontaneous Pregnancy in Patients With Unexplained Recurrent Pregnancy Loss

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04621773
• Other study ID #: 2019SZ-087
• Status: Active, not recruiting
• Start date: September 1, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Preimplantation Genetic Screening
• Recurrent Pregnancy Loss

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
China	Center of Reproductive Medicine, Peking University Third Hospital	Beijing	Haidian

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	the rate of the birth of a living fetus	2 years of following up