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Endometrial Injury and Single Embryo Transfer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01851876
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : July 1, 2013
Last Update Posted : July 1, 2013
Sponsor:
Information provided by (Responsible Party):
Suleyman Guven, Karadeniz Technical University

Study Description
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Brief Summary:
Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.

Condition or disease Intervention/treatment Phase
Primary Infertility Device: Endometrial injury Not Applicable

Detailed Description:
Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down regulation in an IVF patient.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Endometrial injury
The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
 Device: Endometrial injury
Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.
No Intervention: No endometrial injury
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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: up to 6 months ]
  2. Clinical Pregnancy Rate [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851876


Sponsors and Collaborators
Karadeniz Technical University
Investigators
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Principal Investigator: Suleyman Guven Karadeniz Technical University
More Information
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Responsible Party: Suleyman Guven, Assoc. Prof., Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT01851876    
Other Study ID Numbers: 2011/20
First Posted: May 13, 2013    Key Record Dates
Results First Posted: July 1, 2013
Last Update Posted: July 1, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Infertility