Back to resultsEndometrial Injury and Single Embryo Transfer
Primary Purpose
Primary Infertility
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endometrial injury
Sponsored by
About this trial
This is an interventional treatment trial for Primary Infertility
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Endometrial injury
No endometrial injury
Arm Description
The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
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.
Outcomes
Primary Outcome Measures
Clinical Pregnancy Rate
Clinical Pregnancy Rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01851876
First Posted
April 26, 2013
Last Updated
May 11, 2013
Sponsor
Karadeniz Technical University
1. Study Identification
Unique Protocol Identification Number
NCT01851876
Brief Title
Endometrial Injury and Single Embryo Transfer
Official Title
Endometrial Injury May Increase the Clinical Pregnancy Rate in Normoresponders Underwent Long Agonist Protocol Intracytoplasmic Sperm Injection Cycles With Single Embryo Transfer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karadeniz Technical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial injury
Arm Type
Experimental
Arm Description
The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
Arm Title
No endometrial injury
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endometrial injury
Intervention Description
Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Time Frame
up to 6 months
Title
Clinical Pregnancy Rate
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suleyman Guven
Organizational Affiliation
Karadeniz Technical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Endometrial Injury and Single Embryo Transfer
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