Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

Infertility Clinical Trial

Official title:

The Clinical Results After Frozen-thawed Healthy Blastocyst Transfer in Natural Cycle Versus Cycle With Endometrial Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378584
• Other study ID #: CC1978MA
• Status: Completed
• Phase: N/A
• First received: February 6, 2015
• Last updated: January 27, 2016
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: July 2015
• Source: European Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

Inclusion Criteria:

• frozen-thawed healthy blastocyst

Exclusion Criteria:

• post thawed not survival healthy blastocyst

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• embryo transfer
healthy blastocyst transfer in natural and hormonal cycle

Locations

Country	Name	City	State
Italy	European Hospital	Rome	RM
Italy	European Hospital	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
European Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity		12 weeks after embryo transfer	Yes
Secondary	live-birth rate confirmed by the number of born		term pregnancy delivery	Yes
Secondary	cost-benefit of two endometrial preparation protocol	Assessment of drug cost and the count of clinical visit, laboratory dosages and venous sampling	30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test	Yes
Secondary	The number of patients with the anxiety and depression increase	the psychological questionnaire (HADS) administered on four time point	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	Yes