Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: embryo transfer

• Registration Number: NCT02378584
• Lead Sponsor: European Hospital

Brief Summary

This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.

Detailed Description

The aim of the study was to verify the implantation capacity and ongoing pregnancy rate of vitrified warmed euploid blastocyst in natural cycle versus endometrial artificial cycle with gonadotropin-releasing hormone (GnRH-agonist) pituitary suppression.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

Inclusion Criteria

• frozen-thawed healthy blastocyst

Exclusion Criteria

• post thawed not survival healthy blastocyst

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
natural cycle	embryo transfer	Ultrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer
hormonal cycle	embryo transfer	Ultrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity	12 weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
The number of patients with the anxiety and depression increase	Six weeks beginning on the day of treatment start, on the day of progesterone administration, on the day of blastocyst transfer and the pregnancy test	the psychological questionnaire (HADS) administered on four time point
cost-benefit of two endometrial preparation protocol	30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test	Assessment of drug cost and the count of clinical visit, laboratory dosages and venous sampling
live-birth rate confirmed by the number of born	term pregnancy delivery

Trial Locations

Locations (1)

European Hospital; 🇮🇹 Rome, Roma, Italy