Endometrial Injury and Single Embryo Transfer

Primary Infertility Clinical Trial

Official title:

Endometrial Injury May Increase the Clinical Pregnancy Rate in Normoresponders Underwent Long Agonist Protocol Intracytoplasmic Sperm Injection Cycles With Single Embryo Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851876
• Other study ID #: 2011/20
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: May 11, 2013
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2013
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Infertility

Intervention

Device:
• Endometrial injury
Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rate		up to 6 months	No
Primary	Clinical Pregnancy Rate		4 months	No