Effect of Seminal Plasma Insemination on Pregnancy Rates... | NCT01809366

Studies
Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET

NCT01809366

Sponsor

Assaf-Harofeh Medical Center

Status

Completed

Last Update Posted

Mar 12, 2013Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Effect on Implantation and Pregnancy Rates

Interventions

seminal plasma insemination

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Mar 10, 2013

First Submission Date that Met QC Criteria

Mar 10, 2013

First Posted Date

Mar 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2013

Last Update Posted Date

Mar 12, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
seminal plasma insemination	Experimental	seminal plasma insemination	Procedure: seminal plasma insemination
culture medium insemination	Placebo Comparator	culture medium insemination	Procedure: seminal plasma insemination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
seminal plasma insemination	Procedure		culture medium insemination seminal plasma insemination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
implantation rate		4 weeks after ET

Secondary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate		4 weeks after ET
ongoing pregnancy rate		6 weeks after ET

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing oocyte pick up for IVF treatment

Exclusion Criteria:

endometriosis
low responders
uterine malformations

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

41 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Infertility and IVF Unit, Assaf harofeh Medical Center		Zrifin			Israel