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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT03162315
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 29.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Pregnancy Rate	Procedure: Freeze all	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Aug 3, 2018
• Actual Study Completion Date: Aug 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Fresh embryo transfer fresh embryo transfer (standard of care)
Experimental: Freeze all Vitrification of all embryos and replacement of a thawed embryo in a subsequent cycle	Procedure: Freeze all

Outcome Measures

Primary Outcome Measures

1. Clinical pregnancy rate [7 gestational weeks]

Secondary Outcome Measures

1. Ongoing pregnancy rate [25 gestational weeks]

2. Live birth rate [Delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital - Department of Reproductive Medicine	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Frank Vandekerckhove, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT03162315
• Other Study ID Numbers: B670201627451
• First Posted: May 22, 2017
• Last Update Posted: Apr 2, 2020
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Apr 2, 2020