Sponsor study identifier
interventional
20
1 country
1
Study Start
September 2014
Actual (reported)Primary Completion
November 2018
Actual (reported)Study Completion
March 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2014
Actual (reported)June 7, 2015
Actual (reported)June 24, 2015
Actual (reported)November 2018
Actual (reported)March 2020
Actual (reported)cytokine
Measurement of cytokines in endometrial sample in both group.
1month
growth factor
Measurement of growth factors in endometrial sample in both groups.
1month
Expression of TLRs
1month
Expression of HOX
1month
pregnancy rate
6months
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).
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).
The endometrial injury which is induced with pipelle.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royan Institute
Tehran, Iran
Hamid Gourabi, PhD
Head of Royan Institute
Reza Aflatoonian, PhD
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Mahnaz Ashrafi, MD
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Samaneh Aghajanpour, M.S.c
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
20 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2015
First Posted
June 24, 2015
Study Start
September 2014
Actual (reported)Contact the study team to confirm eligibility.
Elham Amirchaghmaghi, MD,PhD
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Primary Completion
November 2018
Actual (reported)Study Completion
March 2020
Actual (reported)Last Updated
September 9, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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