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NCT Number: NCT02480127

Molecular Evaluation of Endometrium After Endometrial Injury

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.

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Key information

Conditions

Endometrial Injury

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royan Institute

Tehran, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PIPELLE Endometrial injury

Procedure

The endometrial injury which is induced with pipelle.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Jun 24, 2015
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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