NCT03186170

Brief Summary

The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

1 month

First QC Date

May 22, 2017

Last Update Submit

July 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • In vitro fertilization: Rate of embryo fertilizated

    we will asses the rate of embryo fertilizated

    two weeks

Secondary Outcomes (1)

  • Embryo development after IVF: Rate of embryo development

    two weeks

Study Arms (2)

SSA

EXPERIMENTAL

The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSA versus traditional technique of swin up) as well as embryo development. In this arm, the sperm selection for IVF will be performed by the new proposed technique of Sperm Selection Assay which consist to expose spermatozoa a progesterone quemoatractant Sperm selection via SSA technique

Other: SSA sperm selection

control

ACTIVE COMPARATOR

The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up for sperm selection) as well as embryo development. In this arm, the sperm selection for IVF will be the traditional swin up technique with different Percoll gradient Sperm selection via traditional swin-up

Other: SSA sperm selection

Interventions

The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.

SSAcontrol

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • infertile women who will partcipate in an IVF programme

You may not qualify if:

  • male factor of infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13083888, Brazil

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 22, 2017

First Posted

June 14, 2017

Study Start

June 1, 2017

Primary Completion

July 15, 2017

Study Completion

July 15, 2017

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations