NCT03162315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2018

Completed
Last Updated

April 2, 2020

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

March 23, 2016

Last Update Submit

March 31, 2020

Conditions

Clinical Pregnancy Rate

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    7 gestational weeks

Secondary Outcomes (2)

  • Ongoing pregnancy rate

    25 gestational weeks

  • Live birth rate

    Delivery

Study Arms (2)

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

Freeze allPROCEDURE
Freeze all

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital - Department of Reproductive Medicine

Ghent, 9000, Belgium

Location

Study Officials

  • Frank Vandekerckhove, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

May 22, 2017

Study Start

March 1, 2016

Primary Completion

August 3, 2018

Study Completion

August 3, 2018

Last Updated

April 2, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)