The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer

Endometrial Receptivity Clinical Trial

— ERA RCT  

Official title:

Clinical Study, International, Multicentre, Prospective, Randomised, Interventional and Controlled, Comparing Fresh Embryo Transfer (ET) Versus Frozen Embryo Transfer (FET) and Personalised Embryo Transfer (pET) Guided by the ERA (Endometrial Receptivity Analysis) Test as a Diagnostic Tool in Patients Treated by IVF/ICSI (in Vitro Fertilisation; Intra-cytoplasmic Sperm Injection)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954758
• Other study ID #: 1304-C-107-CS
• Status: Completed
• Phase: N/A
• Start date: November 25, 2013
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2019
• Source: Igenomix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.

Description:

This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer.

A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

1. Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.

2. Age = 37 years

3. BMI: 18.5 to 30

4. Normal ovarian reserve (AFC = 8; FSH < 8)

5. The most appropriated stimulation protocol will be decided by their doctor.

6. Blastocyst transfer (on day 5 or 6)

7. Blastocyst vitrification with open protocols (Cryotop, Cryoleaf, or Cryolock) or closed protocols (Cryotip or CBSStraw.)

8. Any pathology affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx affecting the endometrial cavity must be previously operated.

Exclusion Criteria:

1. Patients with recurrent miscarriages (> 2 previous biochemical pregnancies or > 2 spontaneous miscarriages)

2. Patients with a severe male factor (spermatozoa < 2 million/ml)

3. Patients with implantation failure (>3 failed cycles with good quality embryos)

Post-Randomization Exclusion Criteria:

1. Endogenous progesterone level = 1,5 ng/ml at the day of hCG administration in all groups.

2. Absence of blastocysts (day 5 or 6) for embryo transfer.

3. Risk of ovarian hyperstimulation syndrome in any of the three groups and therefore a clinical indication to cancel the transfer cycle where the stimulated patient is from group A (ET).

Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those cycles in which PGT-A was performed will be included

Related Conditions & MeSH terms

• Endometrial Receptivity

Intervention

Other:
• personalized Embryo Transfer (pET)

• Frozen Embryo Transfer (FET)

• Fresh Embryo Transfer (ET)

Locations

Country	Name	City	State
Belgium	Centre of Reproductive Medicine UZ Brussles	Brussels
Brazil	Centro de Infertilidade e Medicina Fetal do Norte Fluminence	Campos dos Goytacazes	Rio De Janeiro
Brazil	Centro de Reproduçao Humana Nilo Frantz	Porto Alegre	Rio Grande Del Sur
Brazil	Centro de Reprodução Governador Mario Covas	Sao Paulo
Bulgaria	Sofia Hospital of Reproductive Medicine - SBALAGRM	Sofia
Japan	Oak Clinic Sumiyoshi	Osaka
Panama	IVI Panama	Panama
Spain	IVI Alicante	Alicante
Spain	IVI Madrid	Aravaca	Madrid
Spain	IVI Barcelona	Barcelona
Spain	IVI Bilbao	Leioa	Bizkaia
Spain	ProcreaTec	Madrid
Spain	IVI Sevilla	Sevilla
Spain	IVI Valencia	Valencia
Spain	IVI Vigo	Vigo	Pontevedra
Turkey	Bahceci Health Group	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Igenomix

Countries where clinical trial is conducted

Belgium,  Brazil,  Bulgaria,  Japan,  Panama,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth delivery rate	Percentage of deliveries that resulted in at least one live birth per embryo transfer.	40 weeks
Secondary	Implantation rate	The percentage of gestational sacs observed divided by the number of embryos transferred	12 weeks
Secondary	Pregnancy rate	The percentage of positive pregnancy test divided by the number of embryo transfers	20 weeks
Secondary	Biochemical pregnancies	A pregnancy diagnosed only by the detection of beta hCG in serum	20 weeks
Secondary	Ectopic pregnancies	A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization or histopathology	20 weeks
Secondary	Clinical miscarriages	Spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age	20 weeks
Secondary	Cumulative pregnancy rate	Cumulative pregnancy rate in the 12 months after the first study embryo transfer	12 months
Secondary	Cumulative implantation rate	Cumulative implantation rate in the 12 months after the first study embryo transfer	12 months
Secondary	Cumulative live birth delivery rate	Cumulative live birth delivery rate per embryo transfer in the 12 months after the first study embryo transfer	12 months