A randomised study of IVF patients to assess whether freezing all of the embryos and transferring them in a later natural, unstimulated cycle results in a higher pregnancy rate than transferring an embryo 5 days after egg collectio

Not Applicable

• Conditions: Infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12612000422820
• Lead Sponsor: Mark Livingstone

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Females of infertile couples for whom controlled ovarian stimulation and IVF with or without ICSI is indicated
Age at least 20 years but not more than 38 years at the time of screening
Regular menstrual cycles with a range of 24-33 days
BMI 18-28
AMH 5-20

Exclusion Criteria

Previous IVF treatment cycle that resulted in <6 follicles on Day 8 ultrasound
More than 2 previous unsuccessful stimulated cycles
History of/or current endocrine abnormality such as polycystic ovary syndrome or evidence of ovarian dysfunction
Any clinically significant abnormal laboratory value (TSH, PRL, SHBG, Test)
Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary
Only one ovary
Contra-indications for the use of gonadotrophins
Alcohol or drug abuse, or history thereof, within the 12 months preceding signing informed consent
Smokers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the clinical pregnancy rate in each group, defined as a fetal heartbeat seen on ultrasound at 7 weeks.[Outcome is assessed by transvaginal ultrasound at 7 weeks.]

Secondary Outcome Measures

Name	Time	Method
The number of good-quality embryos by assessment of morphology by embryologist[At completion of study];Proportion of subjects in each group that had 2 or more embryos suitable for vitrification[At completion of study];Cumulative clinical pregnancy rates[At completion of study];Implantation rate assessed by positive beta hCG serology on day of pregnancy test.<br><br>Clinical miscarriage rate assessed by finding of an intrauterine sac on transvaginal ultrasound but no resulting on going pregnancy[At completion of study];Live birth rates[2 years following completion of study];Perinatal complications of placentation[2 years following completion of study];Blastulation anomalies[2 years following completion of study]