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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02026661
Other study ID # 102160-E
Secondary ID
Status Completed
Phase N/A
First received January 1, 2014
Last updated July 4, 2015
Start date January 2014
Est. completion date February 2014

Study information

Verified date July 2015
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

To determine the association of factors affecting the clinical pregnancy and live birth rates in patients undergoing in vitro fertilization (IVF) who received intracytoplasmic sperm injection (ICSI) and/or laser assisted hatching (LAH) or neither.

After applying the inclusion and exclusion criteria, a total of 400 women who underwent IVF between January 2007 and December 2010 were included in the analysis. Patients were divided into 4 groups; 1) those that did not receive ICSI or LAH, 2) those that received ICSI only, 3) those that received LAH only, and 4) those that received both ICSI and LAH. Univariate and multivariate analyses were performed.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- The present study was a retrospective review of the outcomes of women who underwent IVF with or without intracytoplasmic sperm injection (ICSI) at the Far Eastern Memorial Hospital, Taipei, Taiwan, between January 2007 and December 2010.

Exclusion Criteria:

- Cases in which estradiol levels exceeded 50 pg/mL on the second day of the menstrual cycle were excluded.

- Female minors or disabled persons.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital Banqiao New Taipei

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate of intracytoplasmic sperm injection and laser assisted hatching on in vitro fertilization outcomes of patients with different causes of infertility 3 months No
Secondary Live birth rate of intracytoplasmic sperm injection and laser assisted hatching on in vitro fertilization outcomes of patients with different causes of infertility 1 year No
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