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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02867111
Date of registration:	01/08/2016
Prospective Registration:	Yes
Primary sponsor:	Universidad Nacional de Córdoba
Public title:	Sperm Selection for Infertility Treatment (SSA) SSA
Scientific title:	Application of the Sperm Selection Assay in Assisted in Reproductive Technology
Date of first enrolment:	August 2016
Target sample size:	150
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02867111
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
Phase:	N/A

Countries of recruitment
Argentina

Contacts

Name:	Laura C Giojalas, PhD
Address:
Telephone:	0054 - 351 - 5353800
Email:	lgiojalas@gmail.com
Affiliation:

Name:	Laura C. Giojalas, PhD
Address:
Telephone:
Email:
Affiliation:	National University of Cordoba

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis for primary and secondary infertility

- Healthy females or females with tubal obstruction (uni or bilateral) and/or
endometriosis.

- Clinical diagnosis for unexplained infertility.

- Females between 18 and 40 years old.

- Healthy males between 18 and 50 years old.

- Males with oligozoospermia, teratozoospermia, asthenozoospermia or
asthenoteratozoospermia.

Exclusion Criteria:

- Low complexity assisted reproductive techniques

- In vitro fertilization treatment

- Other medical diagnosis of female infertility besides the inclusion criteria

- Males with oligoasthenoteratozoospermia and oligoasthenozoospermia.

Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Other: Attractant Substance

Procedure: ICSI

Device: Sperm Selection Assay

Primary Outcome(s)

Fertilization rate [Time Frame: within 24 hs]

Secondary Outcome(s)

Birth rate [Time Frame: Up to 42 weeks after positive implantation]

Blastocyst formation rate [Time Frame: within 3 to 5 days after injection]

Degree Fragmentation [Time Frame: within 48hs to 66hs post injection]

Fecundation failures in ICSI rate [Time Frame: Within every cycle of ICSI]

biochemist gestational rate [Time Frame: within 45 days after injection]

clinic gestational rate [Time Frame: within one month after injection]

multiple embryo rate [Time Frame: within a month post injection]

Cycles without transferred embryos rate [Time Frame: within 2 months after recruitment]

Embryo quality [Time Frame: within 48 to 66hs post injection]

Pregnancy rate [Time Frame: within 30 days post injection]

Abortion rate [Time Frame: within 3 months post injection]

Implantation yield [Time Frame: 72 hs post injection]

Transferable embryo rate [Time Frame: within 72hs post injection]

Division rate [Time Frame: within 24-72 hs post injection]

Secondary ID(s)

IUMER-1

PIDC2014-0016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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