Preparing and Timing of the Endometrium in Modified Natural Cycle Frozen-thawed Embryo Transfers

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.

Conditions

• Infertility

Interventions

DRUG

Lutinus + transfer day 6

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.

DRUG

Lutinus + transfer day 7

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.

DRUG

No Lutinus + transfer day 6

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.

DRUG

No Lutinus + transfer day 7

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.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Regionshospitalet Horsens

  collaborator OTHER

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Regionshospitalet Viborg, Skive

  collaborator OTHER

• Anja Bisgaard Pinborg

  lead OTHER

Principal Investigators

• Anja B. Pinborg, Prof., DMSC · Fertility Clinic Rigshospitalet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

41 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-06

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Denmark

Study Locations