A Randomized Controlled Trial Comparing Frozen Embryo Transfer Guided by Endometrial Receptivity Analysis Vs Standard Timing in Patients with Recurrent Implantation Failure

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The pregnancy rate of in vitro fertilisation (IVF) remains around 35% per transfer. Women who are not pregnant following several embryo transfers are regarded as having recurrent implantation failure (RIF), with one of the causes being the asynchronization of the embryo and endometrium. Endometrial receptivity analysis (ERA) may identify the window of implantation and guide the timing of embryo transfer to improve the pregnancy outcomes. However, there is no randomized controlled trial on the clinical effectiveness of ERA in women with RIF. This is a multicenter double-blind randomized controlled trial. All participants will have an endometrial biopsy for ERA in a standard hormonal treatment cycle. They will then be randomly assigned in the central laboratory into the intervention or control group in a 1:1 ratio. At the transfer cycle, participants in the intervention group will have frozen embryo transfer timed according to the results of ERA while those in the control group will have the transfer according to the standard timing. The primary outcome is the ongoing pregnancy rate at 10-12 weeks at their first frozen embryo transfer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Women with recurrent implantation failure

• Women aged \< 40 years

• Body mass index of women between 18.5 (inclusive) and 30 (exclusive) kg/m²

• Women with at least one high quality frozen blastocyst (BB grade or above) and planning to undergo a single blastocyst transfer

• Women who will give written informed consent

Locations
Other Locations
China
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Ernest HY Ng, MD
nghye@hku.hk
+85222553400
Backup
Catherine Hung, MBBS
catherinehmw@gmail.com
+85296148198
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 734
Treatments
Experimental: ERA group
The timing of frozen embryo transfer will be arranged according to the endometrial receptivity analysis result
No_intervention: Control group
Frozen embryo transfer will be arranged according to standard timing, i.e. after 5 days of consecutive progesterone use
Related Therapeutic Areas
Sponsors
Collaborators: Nanfang Hospital, Southern Medical University, Third Affiliated Hospital of Zhengzhou University, Liuzhou Maternity and Child Healthcare Hospital, The University of Hong Kong-Shenzhen Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Kwong Wah Hospital
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov

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