Female Infertility Due to Nonimplantation of OvumNCT02306395
Endometrial Local Injury to Improve the Outcome of Embryo Transfer
A study testing Endometrial local injury in people with Female Infertility Due to Nonimplantation of Ovum, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
The purpose of this study is to determine whether edometrial local injury improves the outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of intervention,and the possible mechanism. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Female Infertility Due to Nonimplantation of Ovum
- What is being tested?
- Endometrial local injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with RIF(≥2) of embyo transfer and uneven echo of endometrium on HCG day(12-14 days)
- Without operation history of uterine cavity in the previous three months
- Who agree to join in the study
Who cannot join
- Women more than 40 years or less than 20 years
- With infectious diseases or endocrine diseases
- Who refuse to participate in the experiment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Navy General Hospital.
Beijing, Beijing Municipality, 100048
Yunhai Chuai, Dr, +8618810892004, wangyh85@foxmail.com
Aiming Wang, Dr, +8618600310258, one_army@sina.com
About this study
Official title: Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.
The purpose of this study is to determine whether edometrial local injury improves the outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of intervention,and the possible mechanism.
Read the detailed description
It is important to evaluate the efficacy of endometrial local injury in assisted reproductive technology(ART),especially on the patients of recurrent implantation failure. Although most trials proved the effectiveness of the intervention of local injury, the subjects of these trials are rarely the patients of repeated implantation failure(RIF). Moreover, the mechanism of endometrial injury is not clear.Our trial may provide further basis for this purpose by comparing to the quality of endometrium in two-dimensional ultrasound.If the technique demonstrates efficacy, it would help the patients with RIF caused by poor conditions of endometrium to deal with the problem of infertility.
- Being tested
- Endometrial local injury
- Keywords
- endometrial local injury, repeated implatation failure, embyo transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial local injuryProcedure or surgery
The way of intervention is to scratch the uterine cavity two cycles by a small spatula in the first 3-5 days after menstrual period.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial local injury | Experimental | Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy. Receives: Procedure: Endometrial local injury |
| The blank group | No intervention | Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.
Measured: 3 months after intervention
Secondary outcomes (6)
the change of three-dimensional ultrasound of uterine cavity before and after intervention
including endometrial thickness, echo, blood flow and uterine cavity volume, uterine vascularization index, flow index.
Measured: in implantation window period(12-14 days)
clinical pregnancy rate
The standards is to detect fetal heart beat by ultrasound.
Measured: an expected average of 7 week after pregnancy
live birth rate
The statistical ratio of live birth rate in two groups
Measured: follow-up for one year after pregnancy
the rate of birth defects
calculate the rate of birth defects in two groups
Measured: follow-up for one year after pregnancy
the expression changes of endometrial inflammatory factors
Detection of inflammatory factors, such as LIF,MIP-1.
---------------------------
Measured: endometrial sampling after local injury ,in the first 3-5 days after menstrual period
infection rate
detection of infection by serum test
Measured: one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Female Infertility Due to Nonimplantation of OvumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunhai Chuai, Navy General Hospital, Beijing
- Investigators
- Aiming Wang, Dr, Principal investigator, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306395
- Sponsor's protocol ID
- LY-2014
- Status last verified
- Jan 2016
- First submitted
- 22 Nov 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Toukhy T, Sunkara S, Khalaf Y. Local endometrial injury and IVF outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Oct;25(4):345-54. doi: 10.1016/j.rbmo.2012.06.012. Epub 2012 Jun 26.
PubMed 22885017Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12.
PubMed 23063812Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.
PubMed 17681303Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.
PubMed 5050152Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.
PubMed 20607003Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
PubMed 12798877Karimzade MA, Oskouian H, Ahmadi S, Oskouian L. Local injury to the endometrium on the day of oocyte retrieval has a negative impact on implantation in assisted reproductive cycles: a randomized controlled trial. Arch Gynecol Obstet. 2010 Mar;281(3):499-503. doi: 10.1007/s00404-009-1166-1. Epub 2009 Jul 1.
PubMed 19568761Baum M, Yerushalmi GM, Maman E, Kedem A, Machtinger R, Hourvitz A, Dor J. Does local injury to the endometrium before IVF cycle really affect treatment outcome? Results of a randomized placebo controlled trial. Gynecol Endocrinol. 2012 Dec;28(12):933-6. doi: 10.3109/09513590.2011.650750. Epub 2012 Sep 3.
PubMed 22943664Parsanezhad ME, Dadras N, Maharlouei N, Neghahban L, Keramati P, Amini M. Pregnancy rate after endometrial injury in couples with unexplained infertility: A randomized clinical trial. Iran J Reprod Med. 2013 Nov;11(11):869-74.
PubMed 24639710Gnainsky Y, Granot I, Aldo PB, Barash A, Or Y, Schechtman E, Mor G, Dekel N. Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil Steril. 2010 Nov;94(6):2030-6. doi: 10.1016/j.fertnstert.2010.02.022. Epub 2010 Mar 24.
PubMed 20338560
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.
- ClinicalTrials.gov ID
- NCT02306395
- Acronym / sponsor ID
- LY-2014
- Keywords
- endometrial local injury, repeated implatation failure, embyo transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether edometrial local injury improves the outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of intervention,and the possible mechanism.
Detailed description
It is important to evaluate the efficacy of endometrial local injury in assisted reproductive technology(ART),especially on the patients of recurrent implantation failure. Although most trials proved the effectiveness of the intervention of local injury, the subjects of these trials are rarely the patients of repeated implantation failure(RIF). Moreover, the mechanism of endometrial injury is not clear.Our trial may provide further basis for this purpose by comparing to the quality of endometrium in two-dimensional ultrasound.If the technique demonstrates efficacy, it would help the patients with RIF caused by poor conditions of endometrium to deal with the problem of infertility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial local injury | Experimental | Procedure: Endometrial local injuryEndometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy. |
| The blank group | No intervention | –Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with RIF(≥2) of embyo transfer and uneven echo of endometrium on HCG day(12-14 days)
- Without operation history of uterine cavity in the previous three months
- Who agree to join in the study
Key exclusion criteria (3 listed)
- Women more than 40 years or less than 20 years
- With infectious diseases or endocrine diseases
- Who refuse to participate in the experiment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial local injuryThe way of intervention is to scratch the uterine cavity two cycles by a small spatula in the first 3-5 days after menstrual period. | Procedure or surgery | Endometrial local injury |
Primary outcome
implantation rate
Time frame: 3 months after intervention
When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.
6 secondary outcomes
the change of three-dimensional ultrasound of uterine cavity before and after intervention
Time frame: in implantation window period(12-14 days)
clinical pregnancy rate
Time frame: an expected average of 7 week after pregnancy
live birth rate
Time frame: follow-up for one year after pregnancy
the rate of birth defects
Time frame: follow-up for one year after pregnancy
the expression changes of endometrial inflammatory factors
Time frame: endometrial sampling after local injury ,in the first 3-5 days after menstrual period
infection rate
Time frame: one week after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 22885017El-Toukhy T, Sunkara S, Khalaf Y. Local endometrial injury and IVF outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Oct;25(4):345-54. doi: 10.1016/j.rbmo.2012.06.012. Epub 2012 Jun 26.
- Background: PubMed 23063812Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12.
- Background: PubMed 17681303Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.
- Results publication: PubMed 5050152Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.
- Results publication: PubMed 20607003Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.
- Results publication: PubMed 12798877Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
- Results publication: PubMed 19568761Karimzade MA, Oskouian H, Ahmadi S, Oskouian L. Local injury to the endometrium on the day of oocyte retrieval has a negative impact on implantation in assisted reproductive cycles: a randomized controlled trial. Arch Gynecol Obstet. 2010 Mar;281(3):499-503. doi: 10.1007/s00404-009-1166-1. Epub 2009 Jul 1.
- Results publication: PubMed 22943664Baum M, Yerushalmi GM, Maman E, Kedem A, Machtinger R, Hourvitz A, Dor J. Does local injury to the endometrium before IVF cycle really affect treatment outcome? Results of a randomized placebo controlled trial. Gynecol Endocrinol. 2012 Dec;28(12):933-6. doi: 10.3109/09513590.2011.650750. Epub 2012 Sep 3.
- Results publication: PubMed 24639710Parsanezhad ME, Dadras N, Maharlouei N, Neghahban L, Keramati P, Amini M. Pregnancy rate after endometrial injury in couples with unexplained infertility: A randomized clinical trial. Iran J Reprod Med. 2013 Nov;11(11):869-74.
- Results publication: PubMed 20338560Gnainsky Y, Granot I, Aldo PB, Barash A, Or Y, Schechtman E, Mor G, Dekel N. Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil Steril. 2010 Nov;94(6):2030-6. doi: 10.1016/j.fertnstert.2010.02.022. Epub 2010 Mar 24.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiming Wang, Dr principal investigator
Navy General Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial local injury in people with Female Infertility Due to Nonimplantation of Ovum, run by Navy General Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Li (+8613548550909, 51261886@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implantation rate (time frame: 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306395, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.