An observational study in Obstructive Azoospermia, Non-obstructive Azoospermia and Obstetric Complication, sponsored by Istituto Clinico Humanitas. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Istituto Clinico Humanitas · Observational
A comparison of reproductive and obstetrical outcomes is retrospectively performed among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia between January 2001 and December 2019.
Azoospermia affects almost 20% of all infertile males and It can be divided into obstructive azoospermia (OA) and nonobstructive azoospermia (NOA). Assisted fertilization with testicular sperm extraction (TESE) and intracytoplasmatic sperm injection (ICSI) has been successfully applied for its treatment.
Review of the literature shows that there is a lack of consensus about reproductive outcomes between men with OA and NOA. No study has ever investigated differences in obstetrical outcomes between these two groups before.
The objective of this study is to retrospectively determine differences in reproductive and obstetrical outcomes among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia.
The primary outcomes that will be investigated include:
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's enrollment of 520 is above the median of 95 across 24 observational studies indexed under Azoospermia.
Browse Azoospermia studies →Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study database will include all the couples who underwent ICSI-TESE cycles between January 2001 and December 2019 at Humanitas Fertility Center after ICSI-TESE for obstructive and nonobstructive azoospermia.
ICSI-TESE cycles not reaching the stage of oocyte retrieval will be excluded.
Inclusion Criteria for obstructive azoospermia group:
Inclusion Criteria for non-obstructive azoospermia group:
Exclusion Criteria:
Couples who underwent ICSI-TESE cycles for obstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center
Procedure: ICSI-TESE; embryo-transfer
Couples who underwent ICSI-TESE cycles for nonobstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center
Procedure: ICSI-TESE; embryo-transfer
The sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer.
Live birth rate (LBR)
Rate of delivery of a living baby after at least 22 weeks of gestation
Time frame: 20 years (2001-2019)
Pregnancy rate
Total number of pregnancies including live births, abortions and fetal death
Time frame: 20 years (2001-2019)
Abortion rate
Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
Time frame: 20 years (2001-2019)
Maternal complications rate
Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension, placenta previa and placental abruption, intrauterine growth restriction.
Time frame: 20 years (2001-2019)
Gestational age
Mean gestational age of the pregnancies considered (written with both weeks and days)
Time frame: 20 years (2001-2019)
Prematurity rate
Rate of pregnancies lasted less than 37 weeks and 0 days
Time frame: 20 years (2001-2019)
Twinning rate
Rate of twin deliveries out of the total number of deliveries
Time frame: 20 years (2001-2019)
Cesarean section rate
Rate of cesarean section deliveries out of the total number of deliveries
Time frame: 20 years (2001-2019)
Birth weight
Mean birth weight of the neonates written in grams.
Time frame: 20 years (2001-2019)
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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