Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

January 27, 2016 updated by: European Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00149
        • European Hospital
    • Roma
      • Rome, Roma, Italy, 00149
        • European Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • frozen-thawed healthy blastocyst

Exclusion Criteria:

  • post thawed not survival healthy blastocyst

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: natural cycle
Ultrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer
Other: embryo transfer
healthy blastocyst transfer in natural and hormonal cycle
Other Names:
  • drug adminstration, clinical controls
Active Comparator: hormonal cycle
Ultrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer
Other: embryo transfer
healthy blastocyst transfer in natural and hormonal cycle
Other Names:
  • drug adminstration, clinical controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity
Time Frame: 12 weeks after embryo transfer
12 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live-birth rate confirmed by the number of born
Time Frame: term pregnancy delivery
term pregnancy delivery
cost-benefit of two endometrial preparation protocol
Time Frame: 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
30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test
The number of patients with the anxiety and depression increase
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Hospital

Investigators

  • Study Director: ERmanno Greco, MD, European Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC1978MA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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