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Molecular Evaluation of Endometrium After Endometrial Injury

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ClinicalTrials.gov Identifier: NCT02480127
Recruitment Status : Unknown
Verified June 2015 by Royan Institute.
Recruitment status was:  Recruiting
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Endometrial Injury Procedure: PIPELLE Endometrial injury Phase 3

Detailed Description:
This study is phase 3 randomized clinical trial that the 20 infertile women with the following conditions will be studied in 2 groups. 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]. 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 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Molecular Evaluation of Endometrium Obtained From Women With Repeated Implantation Failure (RIF) After Endometrial Injury in Compare to Women Without Endometrial Injury; Phase 3 Clinical Trial
Study Start Date : June 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Endometrial injury
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
The endometrial injury which is induced with pipelle.

No Intervention: Control
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).



Primary Outcome Measures :
  1. cytokine [ Time Frame: 1month ]
    Measurement of cytokines in endometrial sample in both group.

  2. growth factor [ Time Frame: 1month ]
    Measurement of growth factors in endometrial sample in both groups.


Secondary Outcome Measures :
  1. Expression of TLRs [ Time Frame: 1month ]
    Evaluation of TLRs expression in endometrial sample in both groups.

  2. Expression of HOX [ Time Frame: 1month ]
    Evaluation of HOX expression in endometrial sample in both groups.

  3. pregnancy rate [ Time Frame: 6months ]
    Evaluation of pregnancy rate in both groups.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • < 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480127


Contacts
Contact: Nasser Aghdami, MD,PhD (+98)23562000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)23562000 ext 414 leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)23562000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)23562000 ext 414    Leara91@gmail.com   
Principal Investigator: Zahra Zandieh, PhD         
Sub-Investigator: Fatemeh sadat Amjadi, M.S.c         
Sub-Investigator: Shahideh Jahanian Sadatmahalleh, PhD         
Sub-Investigator: Reza Salman Yazdi, PhD         
Sub-Investigator: Fatemeh Shahbazi, B.S.c         
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: 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.
Principal Investigator: 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.

Additional Information:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02480127     History of Changes
Other Study ID Numbers: royan-Emb-021
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Wounds and Injuries