Primary InfertilityNCT01851876
Endometrial Injury and Single Embryo Transfer
A study testing Endometrial injury in people with Primary Infertility, run by Karadeniz Technical University.
Trial summary
Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Infertility
- What is being tested?
- Endometrial injury
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman age under 35 years
- history of primary infertility
- normoresponder (antral follicle count 5-10 in one ovary in early follicular phase
- having grade I or II embryos for transfer
- agree to undergo endometrial biopsy during the COH cycle. All patients were stimulated with luteal phase long protocol.
Who cannot join
- endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), any systemic disease, collagen disorder, hypercholesterolemia, sickle cell anemia, and a history of neoplasm; -high risk for or history of OHSS
- using any concurrent medication (e.g., insulin-sensitizing drugs, and GnRH antagonists)
- patients who did not proceed to follicle retrieval
- severe male infertility requiring TESA/TESA
- mullerian tract anomalies
- a history of endometrial instrumentation or surgery within a month of the study
- not agree to undergo endometrial biopsy during the COH cycle.
About this study
Official title: Endometrial Injury May Increase the Clinical Pregnancy Rate in Normoresponders Underwent Long Agonist Protocol Intracytoplasmic Sperm Injection Cycles With Single Embryo Transfer
Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.
Read the detailed description
Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down regulation in an IVF patient.
- Conditions
- Primary Infertility
- Being tested
- Endometrial injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial injuryDevice
Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial injury | Experimental | The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle. Receives: Device: Endometrial injury |
| No endometrial injury | No intervention | The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Measured: up to 6 months
Clinical Pregnancy Rate
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary InfertilityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
- Investigators
- Suleyman Guven, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851876
- Sponsor's protocol ID
- 2011/20
- Status last verified
- May 2013
- First submitted
- 26 Apr 2013
- Last updated
- 1 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Injury May Increase the Clinical Pregnancy Rate in Normoresponders Underwent Long Agonist Protocol Intracytoplasmic Sperm Injection Cycles With Single Embryo Transfer
- ClinicalTrials.gov ID
- NCT01851876
- Acronym / sponsor ID
- 2011/20
- Conditions
- Primary Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Posted 1 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.
Detailed description
Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down regulation in an IVF patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial injury | Experimental | Device: Endometrial injuryThe patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle. |
| No endometrial injury | No intervention | –The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- woman age under 35 years
- history of primary infertility
- normoresponder (antral follicle count 5-10 in one ovary in early follicular phase
- having grade I or II embryos for transfer
- agree to undergo endometrial biopsy during the COH cycle. All patients were stimulated with luteal phase long protocol.
Key exclusion criteria (7 listed)
- endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), any systemic disease, collagen disorder, hypercholesterolemia, sickle cell anemia, and a history of neoplasm; -high risk for or history of OHSS
- using any concurrent medication (e.g., insulin-sensitizing drugs, and GnRH antagonists)
- patients who did not proceed to follicle retrieval
- severe male infertility requiring TESA/TESA
- mullerian tract anomalies
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 injuryEndometrial injury with Endometrial Suction Curette (pipelle) will be performed. | Device | Endometrial injury |
Primary outcome
Clinical Pregnancy Rate
Time frame: up to 6 months
Clinical Pregnancy Rate
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suleyman Guven principal investigator
Karadeniz Technical University
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial injury in people with Primary Infertility, run by Karadeniz Technical University.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 1 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2013.