Comparing FET Guided by ERA Vs Standard Timing in Patients with Recurrent Implantation Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorThe University of Hong Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Women with recurrent pregnancy loss (3 or more biochemical or spontaneous miscarriages)

Either partner with known chromosomal abnormalities including balanced translocations

Women undergoing preimplantation genetic testing

Women with endometrial thickness < 7 mm in the IVF cycle

Trial design

Design model

Parallel

Treatments tested in this trial

  • Frozen embryo transfer according to endometrial receptivity analysis result

    Other intervention

    Frozen embryo transfer will be arranged according to endometrial receptivity analysis result, which will be shown in the form of P+X hours

Treatment groups

734 Participants
are divided into 2 treatment groups
Group A: ERA groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Ongoing pregnancy rate

Pregnancy with fetal pulsation at 10-12 weeks

Time frame
8-10 weeks after embryo transfer

Secondary outcomes

1

Endometrial receptivity status

Number of participants showing out of phase endometrium

Time frame
4 weeks after endometrial biopsy
2

Biochemical pregnancy rate

Number of patients with serum β-hCG ≥ 25 mIU/ml 14 days after embryo transfer / Number of patients who underwent embryo transfer \* 100%

Time frame
14 days after embryo transfer
3

Clinical pregnancy rate

Number of patients with an intrauterine gestational sac on transvaginal ultrasound at the 5th week of pregnancy / Number of patients who underwent embryo transfer \* 100%

Time frame
At 5th week of pregnancy
4

Biochemical miscarriage rate

Number of patients with serum β-hCG ≥ 25 mIU/ml at the 5th week of pregnancy but without a gestational sac on transvaginal ultrasound / Number of biochemical pregnancies \* 100%

Time frame
At 5th week of pregnancy

Other outcomes

Sponsors and contacts

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The University of Hong Kong

Lead sponsor

The University of Hong Kong-Shenzhen Hospital

Collaborator

Kwong Wah Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Liuzhou Maternity and Child Healthcare Hospital

Collaborator

Third Affiliated Hospital of Zhengzhou University

Collaborator

Third Affiliated Hospital, Sun Yat-Sen University

Collaborator