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Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

embryo transfer

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

frozen-thawed healthy blastocyst

Exclusion Criteria:

post thawed not survival healthy blastocyst

Sites / Locations

European Hospital
European Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

natural cycle

hormonal cycle

Arm Description

Ultrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer

Ultrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer

Outcomes

Primary Outcome Measures

clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity

Secondary Outcome Measures

live-birth rate confirmed by the number of born

cost-benefit of two endometrial preparation protocol

Assessment of drug cost and the count of clinical visit, laboratory dosages and venous sampling

The number of patients with the anxiety and depression increase

the psychological questionnaire (HADS) administered on four time point

Full Information

NCT ID

NCT02378584

First Posted

February 6, 2015

Last Updated

January 27, 2016

Sponsor

European Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02378584

Brief Title

Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

236 (Actual)

8. Arms, Groups, and Interventions

Arm Title

natural cycle

Arm Type

Other

Arm Description

Ultrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer

Arm Title

hormonal cycle

Arm Type

Active Comparator

Arm Description

Ultrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer

Intervention Type

Other

Intervention Name(s)

embryo transfer

Other Intervention Name(s)

drug adminstration, clinical controls

Intervention Description

healthy blastocyst transfer in natural and hormonal cycle

Primary Outcome Measure Information:

Title

clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity

Time Frame

12 weeks after embryo transfer

Secondary Outcome Measure Information:

Title

live-birth rate confirmed by the number of born

Time Frame

term pregnancy delivery

Title

cost-benefit of two endometrial preparation protocol

Description

Assessment of drug cost and the count of clinical visit, laboratory dosages and venous sampling

Time Frame

30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test

Title

The number of patients with the anxiety and depression increase

Description

the psychological questionnaire (HADS) administered on four time point

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: frozen-thawed healthy blastocyst Exclusion Criteria: post thawed not survival healthy blastocyst

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ERmanno Greco, MD

Organizational Affiliation

European Hospital

Official's Role

Study Director

Facility Information:

Facility Name

European Hospital

City

Rome

State/Province

ZIP/Postal Code

00149

Country

Italy

Facility Name

European Hospital

City

Rome

State/Province

Roma

ZIP/Postal Code

00149

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

27221477

Citation

Greco E, Litwicka K, Arrivi C, Varricchio MT, Caragia A, Greco A, Minasi MG, Fiorentino F. The endometrial preparation for frozen-thawed euploid blastocyst transfer: a prospective randomized trial comparing clinical results from natural modified cycle and exogenous hormone stimulation with GnRH agonist. J Assist Reprod Genet. 2016 Jul;33(7):873-84. doi: 10.1007/s10815-016-0736-y. Epub 2016 May 24.

Results Reference

derived

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Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

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