Endometrial Injury and Single Embryo Transfer
Endometrial Injury May Increase the Clinical Pregnancy Rate in Normoresponders Underwent Long Agonist Protocol Intracytoplasmic Sperm Injection Cycles With Single Embryo Transfer
1 other identifier
interventional
118
0 countries
N/A
Brief Summary
Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 26, 2013
CompletedFirst Posted
Study publicly available on registry
May 13, 2013
CompletedResults Posted
Study results publicly available
July 1, 2013
CompletedJuly 1, 2013
May 1, 2013
7 months
April 26, 2013
May 11, 2013
May 11, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical Pregnancy Rate
up to 6 months
Clinical Pregnancy Rate
4 months
Study Arms (2)
Endometrial injury
EXPERIMENTALThe patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
No endometrial injury
NO INTERVENTIONThe 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.
Interventions
Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Limitations and Caveats
No limitations.
Results Point of Contact
- Title
- Dr. Suleyman Guven, Director of clinical trial
- Organization
- Karadeniz Technical University, School of Medicine, Dept Obs and Gyn.
Study Officials
- PRINCIPAL INVESTIGATOR
Suleyman Guven
Karadeniz Technical University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
April 26, 2013
First Posted
May 13, 2013
Study Start
September 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
July 1, 2013
Results First Posted
July 1, 2013
Record last verified: 2013-05