Evaluation sperm selection technique on embryo development and pregnancy outcomes

Evaluation the efficiency of human sperm DNA fragmentation test, telomere assay and sperm selection technique on embryo development and pregnancy outcome.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211211053355N1

Enrollment

100

Registered

2022-01-09

Start date

2022-01-21

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male factor infertility with characterized by Teratozoospermia. Male Infertility

Interventions

Intervention 1: Intervention group: Intracytoplasmic Morphologic Examination Sperm Injection (IMSI). In this group, researcher will be selected sperms under inverted microscope with more than 6000x ma

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male participants are characterized by fresh ejaculated spermatozoa with a concentration of at least 5 million/ml , Teratozospermia and having indication for ICSI because of male infertility. female partners aged under 38 years old, without poor ovarian response and having day 3 serum FSH < 15 IU/lit will be entered the study

Exclusion criteria

Exclusion criteria: Testicular samples and ejaculate samples with concentration below 5 million / ml ?female partner with poor ovarian response, endometriosis, and cases with no embryo to transfer.

Design outcomes

Primary

Measure	Time frame
Embryo development. Timepoint: 3 days after microinjection. Method of measurement: Based on Hill's grading.;Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: Evaluation of B HCG in blood serum.;Clinical Pregnancy. Timepoint: 8 weeks after embryo transfer. Method of measurement: detection of embryo heart beat in abdominal sonography.;Fertilization Rate. Timepoint: 16-18 hours after microinjection. Method of measurement: evaluation the formation of 2 pronucleous under the microscope.;Embryo implantation rate. Timepoint: 6weeks after embryo transfer. Method of measurement: detection the number of gestational sac in abdominal sonography.	—

Measure

Time frame

Embryo development. Timepoint: 3 days after microinjection. Method of measurement: Based on Hill's grading.;Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: Evaluation of B HCG in blood serum.;Clinical Pregnancy. Timepoint: 8 weeks after embryo transfer. Method of measurement: detection of embryo heart beat in abdominal sonography.;Fertilization Rate. Timepoint: 16-18 hours after microinjection. Method of measurement: evaluation the formation of 2 pronucleous under the microscope.;Embryo implantation rate. Timepoint: 6weeks after embryo transfer. Method of measurement: detection the number of gestational sac in abdominal sonography.

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Secondary

Measure	Time frame
Evaluation SDF and STL in sperms with scores between 0-6. Timepoint: Before randomization. Method of measurement: Sperm DNA fragmentation test, Sperm Telomere Assay.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Shakeri

Yazd University of Medical Sciences

Fatemehshakeri1359@yahoo.com38247085

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026