se of Cetrotide as a medication in Frozen Embryo Replacement IVF cycles

Phase 1

• Conditions: Infertility; MedDRA version: 20.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-001915-63-GB
• Lead Sponsor: niversity of Oxford / Clinical Trials and Research Governance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

•Healthy female aged 18 >to < 42 years old (up to 42nd birthday at the time of embryo transfer)
•Participant is willing and able to give informed consent for participation in the study.
•Planning to undergo medicated FET
•Blastocyst embryo in storage available for transfer

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Previously randomised into the trial.
•A history of 3 or more failed embryo transfer cycles (fresh or frozen).
•A history of recurrent miscarriage (3 or more consecutive miscarriages).
•Contraindication to the use of medications for FET cycle.
•Biopsied embryos.
•Donor embryos or eggs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To assess the effect on livebirth rate of giving no pituitary suppression during endometrial preparation prior to frozen-thawed embryo transfer versus giving a GnRH antagonist.<br><br> ;Secondary Objective: To assess the effect of giving no pituitary suppression during endometrial preparation prior to frozen-thawed embryo transfer versus giving a GnRH antagonist on the following outcomes:Cancellation rate, Clinical pregnancy rate, Miscarriage rate, Ectopic pregnancy rate, Multiple pregnancy rate, Stillbirth rate, Endometrial thickness. Other secondary outcomes are Patient satisfaction with treatment and feasibility of future larger trial.;Primary end point(s): Livebirth rate per embryo transfer procedure ;Timepoint(s) of evaluation of this end point: Up to end of pregnancy (42 completed weeks gestation)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): •Cycle Cancellation<br> •Adverse cycle events<br> •Endometrial thickness<br> •Patient satisfaction with treatment<br> ;<br> Timepoint(s) of evaluation of this end point: •Cycle Cancellation - Up until date of embryo transfer<br> •Adverse cycle events - various points from start until final outcome i.e. live birth known<br> •Endometrial thickness (at embryo transfer)<br> •Patient satisfaction with treatment (at embryo transfer)<br><br>