Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial

NCT04496232 — Not applicable, Completed, 300 participants, Ganin Fertility Center

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Registry	NCT04496232
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	300 (Actual)
Sponsor	Ganin Fertility Center (Other)
Conditions	Male Infertility
Interventions	PICSI, Second ejaculate (Device, other)
Dates	start 2020-08-01, primary completion 2021-12-01, completion 2021-12-01, first posted 2020-08-03, last updated 2022-08-09
Locations	1 site in Egypt

-Summary

Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.

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+Detailed description

Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.

+Arms and interventions

Arm	Type	Interventions	Description
Normal SDF	No intervention		Using routine semen processing method
Physiological ICSI (PICSI)	Active comparator	Device: PICSI	Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI
Second ejaculate	Active comparator	Other: Second ejaculate	Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI

PICSI (Device): Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
Second ejaculate (Other): Semen processing by density gradient centrifugation for the second ejaculate

+Outcome measures

Primary outcomes

Fertilization rate [16-19 hours]: Defined as the proportion of fertilized oocytes over the injected oocytes.
Cleavage rate [3 days]: Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
Blastulation rate [5-6 days]: Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
Blastocyst quality rate [5-6 days]: Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair, or bad in terms of percentage of the total formed blastocysts.

+Eligibility

Sex: All, ages: 18 Years to 50 Years

Inclusion Criteria:

* Male partner with abnormal sperm DNA fragmentation index (>20%) by TUNEL assay
* Male partner with at least 1 million progressive motile count
* Male aged 18-50 years
* Male with adjusted sexual abstinence days (1-2 days)
* Female aged 18-37 years
* Normo-responder females (at least 5 mature oocytes)

Exclusion Criteria:

* Leukocytospermia
* Varicocele
* Known genetic abnormality
* Use of oocyte or sperm donors
* Use of a gestational carrier
* Presence of any endometrial factors that can affect embryo implantation
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

+Locations (1)

Facility	City	Country	Status
Ganin Fertility Center	Cairo, Cairo Governorate	Egypt

+Investigators

Eman Hasanen, Principal investigator, Ganin Fertility Center
Radwa Omar, Principal investigator, Ganin Fertility Center
Hanaa Alkhader, Principal investigator, Ganin Fertility Center
Hosam Zaki, MSc, FRCOG, Study director, Ganin Fertility Center
Manar Hozayen, MSc., Principal investigator, Ganin Fertility Center