Endometrial Injury and Single Embryo Transfer

NCT ID: NCT01851876

Last Updated: 2013-07-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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

Conditions

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Primary Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endometrial injury

The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.

Group Type EXPERIMENTAL

Endometrial injury

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endometrial injury

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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Suleyman Guven

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suleyman Guven

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Other Identifiers

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2011/20

Identifier Type: -

Identifier Source: org_study_id

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