RCT to Assess the Clinical Benefit of the ERA Test in Infertile Women at Their First IVF/ICSI Cycle

NCT04687670 | Unknown DMC

• 1 other identifier: PUTH ERA 1.0
• Study Type: interventional
• Target: 714
• Locations: 1 country
• Sites: 3

Brief Summary

Endometrial receptivity takes place in a self-limited period of time during the endometrial mid-secretory stage. This period, named as window of implantation (WOI), is modulated by molecular changes allowing embryo implantation to take place. It has been already demonstrated the existence of transcriptomic profiles that are characteristics of each endometrial phase: pre-receptive, receptive and post-receptive. 'Igenomix' group developed a molecular tool able to classify the endometrium based on its transcriptomic profile, the Endometrial Receptivity Analysis (ERA). This molecular tool analyses, by next generation sequencing (NGS), the expression of 248 genes related to implantation coupled to a computational predictor to identify the specific transcriptomic profile for each endometrial stage. This test has been applied at clinical level from 2010, helping to synchronize a viable embryo with a receptive endometrium through the personalized embryo transfer (pET). It aims to improve clinical implantation by personalizing, diagnosing, and synchronizing the endometrial factor. Our goal in this project is to investigate at what extent, if any, the analysis of the endometrial factor, at receptivity level, in patients at their first in vitro fertilization (IVF) cycle improves their clinical outcome through a personalized embryo transfer by the ERA test in comparison to embryo transfer(FET).

Conditions

Infertility, Female; IVF/ICSI

Keywords

Personalized Embryo Transfer; Endometrial Receptivity Analysis; Conventional Frozen Embryo Transfer; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  The number of deliveries that resulted in at least one live birth per ET (transferred patient). Live birth is defined as the complete expulsion or extraction from a woman of a product of conception after 22 weeks of gestation, which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.

  From date of embryo transfer until 40 weeks

Secondary Outcomes (9)

• Implantation rate

  From date of embryo transfer until 5-6 weeks

• Clinical miscarriage rate

  From date of embryo transfer until 20 weeks

• Biochemical pregnancy rate

  From date of embryo transfer until 5-6 weeks

• Ectopic pregnancy rate

  From date of embryo transfer until 8 weeks

• Incidence of WOI displacement in the study population

  From date of randomization until 1-2 months

Other Outcomes (1)

• ERA test validation in endometrial fluid

  From date of randomization until 1-2 months

Study Arms (2)

Intervention group(pET)

EXPERIMENTAL

Personalized embryo transfer of a single vitrified blastocyst in a HRT cycle according to the ERA test results.

Diagnostic Test: ERA

Control group(FET)

ACTIVE COMPARATOR

Frozen embryo transfer of a single vitrified blastocyst in a HRT cycle according to the clinical standard practice.

Diagnostic Test: ERA

Interventions

ERA DIAGNOSTIC_TEST

Before the randomization, Endometrial Fluid (EF) and Endometrial Biopsy (EB) samples will be collected from all participants. EF will be obtained by aspiration immediately prior to the EB after around 120 hours of progesterone (P) impregnation following the standard HRT cycle. The results of the ERA test will be provided to participants and their gynecologists for the personalized embryo transfer.

Intervention group(pET)

Eligibility Criteria

• Age: Up to 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients whose written ICF approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
• Patients undergoing their first IVF/ICSI cycle (first oocyte pick up, freezing all) with their own oocytes that will receive single embryo transfer of frozen blastocyst stage embryos (day 5/6) on an HRT cycle.
• At least 2 morphologically good quality embryos already vitrified in blastocyst stage (day 5/6).
• Maternal Age: ≤37 years to rule out embryo factor in aging patients.
• BMI: 18.5 - 30.0 kg / m2 (both inclusive).
• Normal ovarian reserve (defined as: AFC ≥ 8; AMH level ≥1.0 ng/ml and/or FSH \< 8 mU/ml) before the controlled ovarian stimulation (COS) initiation.
• Serum P levels ≤ 1.5 ng/ml, measured within 24 hours before the hCG administration in the COS cycle.
• Negative serological tests for HIV, HBV, HCV, RPR.

You may not qualify if:

• Patients with repeated miscarriages (\> 2 previous biochemical pregnancies or \> 2 spontaneous miscarriages).
• Male partner with severe male factor (spermatozoa \< 2 million/ml). Semen donor is allowed.
• Patients who are intrauterine device (IUD) carriers in the last 3 months before sample collection.
• Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx must be previously operated at least 3 months before the endometrial samples are obtained. (Note: Patients are allowed to participate if the pathology is corrected before performing any study procedure).
• Embryos analysed using preimplantation genetic testing for aneuploidies (PGT-A).
• Any illness or medical condition that is unstable or affect the safety of the patient and compliance of the study.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• RenJi Hospital: collaborator
• Northwest Women's and Children's Hospital, Xi'an, Shaanxi: collaborator

Study Sites (3)

Northwest Women's and Children's Hospital

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Renji Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Jie Qiao

  Peking University Third Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Qiao

CONTACT

+86 010-82266699; Jie.quiao@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 29, 2020
• Study Start: August 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: July 8, 2021

Record last verified: 2021-04

Locations

CN (3)