The Value of Progesterone for the Timing of the Embryo Tr... | NCT03162315

Studies
The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial

NCT03162315

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Apr 2, 2020Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Clinical Pregnancy Rate

Interventions

Freeze all

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Aug 3, 2018Actual

Completion Date

Aug 3, 2018Actual

First Submitted Date

Mar 23, 2016

First Submission Date that Met QC Criteria

May 19, 2017

First Posted Date

May 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

Description Module

Brief Summary

At the start of the controlled ovarian stimulation as a part of the IVF/ICSI treatment patients are informed about this trial. In case they gave informed consent and they have a progesterone level between 1 and 1.5 ng/ml at the day of the hCG injection, they will be randomised. One group of patients will have a fresh embryo transfer, in the second group all embryos will be cryopreserved and transfered in a subsequent (natural or artificial) cycle. The aim of this study is to compare clinical pregnancy rate between the two groups.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fresh embryo transfer	No Intervention	fresh embryo transfer (standard of care)
Freeze all	Experimental	Vitrification of all embryos and replacement of a thawed embryo in a subsequent cycle	Procedure: Freeze all

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Freeze all	Procedure		Freeze all

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate		7 gestational weeks

Secondary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy rate		25 gestational weeks
Live birth rate		Delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IVF/ICSI treatment
progesterone > 1 ng/ml and ≤ 1.5 ng/ml

Exclusion Criteria:

> 40 years
AMH ≤ 1 ng/ml
Conditions influencing pregnancy rate (e.g. hydrosalphinx, uterus malformation, hyperprolactinemia and other endocrine conditions; with the exception of controlled thyroid function disease)
no available progesterone value on the day of hCG-injection

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Vandekerckhove, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University Hospital - Department of Reproductive Medicine		Ghent		9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided