Molecular Evaluation of Endometrium After Endometrial Injury

NCT02480127 | Completed DMC

• 1 other identifier: royan-Emb-021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Repeated implantation failure (RIF) is determined when failure of implantation occurred during at least three consecutive IVF attempts while at least one high-grade embryo was transferred in each cycle. Several methods have been suggested to improve the implantation rate in RIF patients. One of the most promising methods is local injury to the endometrium. It has been reported that the rates of implantation, clinical pregnancy, and live birth reach more than double in RIF patients with local endometrial injury than patients without it. The population of this study included all infertile couples attending the Royan Institute, who have at least three consecutive cycles of ART failure. Also this study is phase 3 randomized clinical trial. Based on the average menstrual cycle 30-28 days, endometrial and blood samples were collected from two groups of patients on day 21 of luteal phase of their spontaneous menstrual cycle. The intervention, but not the control group underwent prior biopsy treatment in follicular phase on days 8 or/and 11 to 13 of that same cycle but in these days blood sample in both groups were collected. To investigate the impact of local endometrial injury in increasing the rate of pregnancy in ART - treated RIF patients, the investigators will examine the changes of immunological factors involved in the implantation including some cytokines, growth factors ( in serum and endometrial biopsies) and the expression of TLRs and HOX genes ( in endometrial biopsies) obtained from both groups.

Conditions

Endometrial Injury

Outcome Measures

Primary Outcomes (2)

• cytokine

  Measurement of cytokines in endometrial sample in both group.

  1month

• growth factor

  Measurement of growth factors in endometrial sample in both groups.

  1month

Secondary Outcomes (3)

• Expression of TLRs

  1month

• Expression of HOX

  1month

• pregnancy rate

  6months

Study Arms (2)

Endometrial injury

EXPERIMENTAL

In the intervention group, endometrial sampling is obtained twice by Pipelle \[one in the follicular phase (during 8-9 or 11- 13 day in the beginning of buserelin cycle) and the last in the luteal phase (during 19-21 or 20-23 day) preceding the embryo transfer cycle preceding the embryo transfer cycle\]. Blood samples (5- 10 cc) are taken in the both groups twice (one on the 9-8 or 11- 13 day and 19-21 or 20-23 day preceding the embryo transfer cycle).

Procedure: PIPELLE Endometrial injury

Control

NO INTERVENTION

In the control group endometrial sampling will be done only in the luteal phase of the cycle preceding the embryo transfer cycle. Blood samples (5- 10 cc) are taken twice (one on the 9-8 or 11- 13 day and 19-21 or 20-23 day preceding the embryo transfer cycle).

Interventions

PIPELLE Endometrial injury PROCEDURE

The endometrial injury which is induced with pipelle.

Endometrial injury

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< 40 years old
• Patients had history of 3 failed consecutive cycles of IVF / ICSI.
• Patients were good responders in prior ovulation induction cycle.
• There were at least two embryos with grade A in each embryo transfer cycle.
• Normal uterus in Hysterosalpingography (HSG) or ultrasound or hysteroscopy scans.
• The minimum thickness of the endometrium is 7 mm in injection day.

You may not qualify if:

• Submucosal myoma.
• Intramural and sub serousal myoma greater than 5 cm.
• Endometrioma equal to or greater than 3 cm or Hydrosalpinx.
• The number of available embryos is less than 2 in the current cycle.
• Patients with endometrial tuberculosis and persons who are treated for tuberculosis.
• Patients with any specific drug consumption.
• Patients with a history of thyroid disease, diabetes and other endocrine disorders.
• Lost to follow up or sampling.
• Impossibility of prepare endometrial sampling because of severe pain or probability infection.

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Reza Aflatoonian, PhD

  Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

  STUDY DIRECTOR

• Mahnaz Ashrafi, MD

  Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

  STUDY DIRECTOR

• Samaneh Aghajanpour, M.S.c

  Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

• Elham Amirchaghmaghi, MD,PhD

  Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2015
• First Posted: June 24, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: March 1, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

IR (1)