InfertilityNCT02409745
The Effectiveness of Endometrial Injury in IVF
A study testing endometrial scratch in people with Infertility, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate in patients undergoing in vitro fertilization and embryo transfer. However, only a limited number of studies have been conducted in frozen thawed transfer (FET) cycle. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- endometrial scratch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Feb 2016
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be aged younger than 40 years old;
- At least one period IVF-ET (fresh or thaw) has been done and not pregnant after at least one qualified blastocyst (more than 3BB) or two qualified embryos (more than II/6) have been transferred;
- There are qualified embryos thawed and the thaw-ET period will be taken.
Who cannot join
- Malformation of uterus: such as uterus uni-corns, uterus bi-corns, untreated uterus septus, etc.;
- History of endometrial diseases: such as intrauterine adhesion, uterine cavity tuberculosis, severe dysplasia of endometrium, etc.;
- Multiple myomata or endometrioma which causes uterus oppression;
- Multiple and recurrent endometrial polyps;
- Pelvic tuberculosis, endometriosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yang Wang, M.D
About this study
Official title: The Effectiveness of Endometrial Injury in Different Phase of Menstrual Cycle:a Prospective Controlled Clinical Study
Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate in patients undergoing in vitro fertilization and embryo transfer. However, only a limited number of studies have been conducted in frozen thawed transfer (FET) cycle. Nowadays, in FET cycles, endometrial scratch is mainly performed on two different time points: 1) luteal phase in the previous cycle; 2)early follicular phase in the current cycle. However, few studies have compared the effectiveness of those two different endometrial scratch methods performed in different timing. The aim of this study is to find the best timing of endometrial scratch in FET cycles.
- Conditions
- Infertility
- Being tested
- endometrial scratch
- Keywords
- endometrial scratch, IVF, randomized controlled study, Prospective controlled trial, Different time to perform endometrial scratch, In vitro fertilization, embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial scratchProcedure or surgery
Also called endometrial injury
local injury to the endometrium by Pipelle
| Study group | Role | What they receive |
|---|---|---|
| Young age group-Luteal phase | Experimental | Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer. Receives: Procedure: endometrial scratch |
| Young age group-Early follicular phase | Active comparator | Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer. Receives: Procedure: endometrial scratch |
| Advanced age group-Luteal phase | Experimental | Endometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer. Receives: Procedure: endometrial scratch |
| Advanced age group-Early follicular phase | Active comparator | Endometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer. Receives: Procedure: endometrial scratch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
See heart beat with ultrasonic exam.
Measured: 35 days after embryo transfer
Secondary outcomes (1)
Ectopic pregnancy rate
No sac can be seen inside uterine 35 days after embryo transfer, but with high hCG level
Measured: 35 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Yingpu Sun, MD,PhD, Study chair, Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409745
- Sponsor's protocol ID
- RMCZZU-EEI
- Status last verified
- Apr 2015
- First submitted
- 6 Jan 2015
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yeung TW, Chai J, Li RH, Lee VC, Ho PC, Ng EH. The effect of endometrial injury on ongoing pregnancy rate in unselected subfertile women undergoing in vitro fertilization: a randomized controlled trial. Hum Reprod. 2014 Nov;29(11):2474-81. doi: 10.1093/humrep/deu213. Epub 2014 Sep 8.
PubMed 25205759Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3.
PubMed 25803542Potdar 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 23063812El-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 22885017Dain L, Ojha K, Bider D, Levron J, Zinchenko V, Walster S, Dirnfeld M. Effect of local endometrial injury on pregnancy outcomes in ovum donation cycles. Fertil Steril. 2014 Oct;102(4):1048-54. doi: 10.1016/j.fertnstert.2014.06.044. Epub 2014 Jul 23.
PubMed 25064410
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Endometrial Injury in Different Phase of Menstrual Cycle:a Prospective Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02409745
- Acronym / sponsor ID
- RMCZZU-EEI
- Conditions
- Infertility
- Keywords
- endometrial scratch, IVF, randomized controlled study, Prospective controlled trial, Different time to perform endometrial scratch, In vitro fertilization, embryo transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 7 Apr 2015 (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.
Many studies have demonstrated that endometrial scratch significantly increase pregnancy rate in patients undergoing in vitro fertilization and embryo transfer. However, only a limited number of studies have been conducted in frozen thawed transfer (FET) cycle. Nowadays, in FET cycles, endometrial scratch is mainly performed on two different time points: 1) luteal phase in the previous cycle; 2)early follicular phase in the current cycle. However, few studies have compared the effectiveness of those two different endometrial scratch methods performed in different timing. The aim of this study is to find the best timing of endometrial scratch in FET cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young age group-Luteal phase | Experimental | Procedure: endometrial scratchEndometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer. |
| Young age group-Early follicular phase | Active comparator | Procedure: endometrial scratchEndometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer. |
| Advanced age group-Luteal phase | Experimental | Procedure: endometrial scratchEndometrial injury in luteal phase (previous menstrual cycle) for patients undergoing Frozen thawed embryo transfer. |
| Advanced age group-Early follicular phase | Active comparator | Procedure: endometrial scratchEndometrial injury in early follicular phase for patients undergoing Frozen thawed embryo transfer. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- To be aged younger than 40 years old;
- At least one period IVF-ET (fresh or thaw) has been done and not pregnant after at least one qualified blastocyst (more than 3BB) or two qualified embryos (more than II/6) have been transferred;
- There are qualified embryos thawed and the thaw-ET period will be taken.
Key exclusion criteria (5 listed)
- Malformation of uterus: such as uterus uni-corns, uterus bi-corns, untreated uterus septus, etc.;
- History of endometrial diseases: such as intrauterine adhesion, uterine cavity tuberculosis, severe dysplasia of endometrium, etc.;
- Multiple myomata or endometrioma which causes uterus oppression;
- Multiple and recurrent endometrial polyps;
- Pelvic tuberculosis, endometriosis.
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 scratchAlso: endometrial injurylocal injury to the endometrium by Pipelle | Procedure or surgery | Advanced age group-Early follicular phase, Advanced age group-Luteal phase, Young age group-Early follicular phase, Young age group-Luteal phase |
Primary outcome
Clinical pregnancy rate
Time frame: 35 days after embryo transfer
See heart beat with ultrasonic exam.
1 secondary outcome
Ectopic pregnancy rate
Time frame: 35 days after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Background: PubMed 25205759Yeung TW, Chai J, Li RH, Lee VC, Ho PC, Ng EH. The effect of endometrial injury on ongoing pregnancy rate in unselected subfertile women undergoing in vitro fertilization: a randomized controlled trial. Hum Reprod. 2014 Nov;29(11):2474-81. doi: 10.1093/humrep/deu213. Epub 2014 Sep 8.
- Background: PubMed 25803542Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3.
- 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 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 25064410Dain L, Ojha K, Bider D, Levron J, Zinchenko V, Walster S, Dirnfeld M. Effect of local endometrial injury on pregnancy outcomes in ovum donation cycles. Fertil Steril. 2014 Oct;102(4):1048-54. doi: 10.1016/j.fertnstert.2014.06.044. Epub 2014 Jul 23.
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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.
Yingpu Sun, MD,PhD study chair
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
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 scratch in people with Infertility, run by The First Affiliated Hospital of Zhengzhou University 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 5 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 21 Apr 2015. 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 Yingpu Sun, MD,PhD (86-13803841888, syp2008@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 35 days after embryo transfer). 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 NCT02409745, which also lists 5 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 21 Apr 2015.