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

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

Study Overview

• Status: Completed
• Conditions: Primary Infertility
• Intervention / Treatment: Device: Endometrial injury

Detailed Description

Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down regulation in an IVF patient.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Pregnancy Rate	up to 6 months
Clinical Pregnancy Rate	4 months

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Suleyman Guven, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: May 11, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2011/20