NCT02328534

Brief Summary

The investigators evaluate the feedback of using swim down semen processing method during preparation for ICSI and compare the results of pregnancy and embryos quality with the cases used density gradient method for their semen processing.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
890

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

6.5 years

First QC Date

December 28, 2014

Last Update Submit

December 30, 2014

Conditions

Infertility

Keywords

ICSI/IVFSemen processingSemen preparationSwim downDensity gradientSilica solution

Outcome Measures

Primary Outcomes (1)

  • Total Pregnancy Rate

    Percentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.

    3 Years

Secondary Outcomes (2)

  • Blastulation Rate (BR)

    3 years

  • Blastocyst formation Rate (BFR)

    3 Years

Study Arms (2)

Density Gradient semen

ICSI Cases processed using DG semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate

Behavioral: Blastocyst Formation RateProcedure: Blastocyst RateProcedure: Pregnancy Rate

Swimming down semen

ICSI Cases processed using SD semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate

Behavioral: Blastocyst Formation RateProcedure: Blastocyst RateProcedure: Pregnancy Rate

Interventions

Blastocyst Formation RateBEHAVIORAL

Embryos developed at Day3 cultures, are continued for Day5 culture tho reach blastocyst stage. The percentage of blastocyst produced from cleaved embryos to be evaluated ar rate. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.

Also known as: Blastocyst developed form cleaved embryos
Density Gradient semenSwimming down semen
Blastocyst RatePROCEDURE

Day 5 embryo transfer achieved pregnancy are compared with total embryo transfer cases at Day5. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam.

Also known as: Pregnancey produced formblastocyst embryo transfer
Density Gradient semenSwimming down semen
Pregnancy RatePROCEDURE

All pregnancy achieved from all ET. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.

Also known as: Pregnancy achieved after all ET
Density Gradient semenSwimming down semen

Eligibility Criteria

Age20 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Cases collected were submitted for ART treatment using ICSI/IVF procedures. In two different IVF clinics at Manama-Bahrain and Sohag-Egypt. The groups of about 890 couple prepared for treatment.

You may qualify if:

  • Cases have semen examination criteria fall within WHO 2010 standards of count
  • Cases have semen examination criteria fall within WHO 2010 standards of motility
  • Cases have semen examination criteria with all types of abnormal forms
  • Cases produced more than 4 mature oocytes (M2) and more

You may not qualify if:

  • Cases have semen examination criteria with motility less than 5%
  • Cases have semen examination criteria with count less than 1.0 million
  • Cases with TESE, TESA and EPSA, both fresh and frozen
  • Cases produced less than 4 mature oocytes (M2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al Baraka Fertility Hospital

Manama, Adliyah, 15006, Bahrain

Location

Ibn Sina IVF Center- Ibn Sina Hospital

Sohag, Sohag Governorate, 15006, Egypt

Location

Related Publications (1)

  • Malvezzi H, Sharma R, Agarwal A, Abuzenadah AM, Abu-Elmagd M. Sperm quality after density gradient centrifugation with three commercially available media: a controlled trial. Reprod Biol Endocrinol. 2014 Dec 2;12:121. doi: 10.1186/1477-7827-12-121.

    PMID: 25466430RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Semen samples Embryos processed after ICSI and IVF cycles.

MeSH Terms

Conditions

Infertility

Interventions

Pregnancy Rate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Vital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Ahmad M Metwalley, Ms. Genetics

    Adliyah

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Novel Approach of Semen Preparation to Improve ICSI Outcome

Study Record Dates

First Submitted

December 28, 2014

First Posted

December 31, 2014

Study Start

March 1, 2007

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

BA(1)EG(1)