CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 679 enrolled
Drug / intervention
Lutinus + transfer day 6 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03795220
NCT03795220Phase 4Completed
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Preparing and Timing of the Endometrium in Modified Natural Cycle Frozen-thawed Embryo Transfers (mNC-FET) - a Randomized Controlled Multicenter Trial

Anja Bisgaard Pinborg·interventional·Posted Jan 7, 2019·Updated May 15, 2025

In Brief

A Phase 4 clinical trial evaluating Lutinus + transfer day 6, Lutinus + transfer day 7, and 2 other interventions for Infertility. Completed, enrolled 679 participants across 1 site.

Detailed Summary

The increasing use of FET emphasizes the importance of preparing and timing the endometrium in FET cycles, however there is no consensus on luteal phase progesterone supplementation in mNC-FET and the optimal day of blastocyst warming and transfer. The aim of this multicenter RCT is to assess the effect of progesterone supplementation in hCG-triggered mNC-FET and the effect of embryo thawing and transfer at hCG+6 or hCG+7 days, respectively. In total 604 patients will be included with n=151 in each of the four study arms. The primary outcome is live birth rate per transfer (LBR) and the goal is to show a 10% increase in LBR after progesterone supplementation and to assess whether blastocyst warming+transfer 6 days after hCG trigger is superior to 7 days after hCG trigger in mNC-FET.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesDenmark
CollaboratorsCopenhagen University Hospital, Hvidovre, Regionshospitalet Horsens, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Hillerod Hospital, Denmark, Zealand University Hospital, Regionshospitalet Viborg, Skive

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 7, 2019
Enrollment StartJan 6, 2019
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 7.5 years ago

Interventions

Lutinus + transfer day 6drug

Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.

Lutinus + transfer day 7drug

Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.

No Lutinus + transfer day 6drug

Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.

No Lutinus + transfer day 7drug

Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.