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Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia

Reproductive and Obstetric Outcomes in TESE-ICSI Cycles: a Comparison Between Obstructive and Non-obstructive Azoospermia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04894136
Acronym
AZOOCOMES
Enrollment
520
Registered
2021-05-20
Start date
2001-01-01
Completion date
2019-12-31
Last updated
2021-05-20

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

Conditions

Non-obstructive Azoospermia, Obstetric Complication, Obstructive Azoospermia

Keywords

Reproductive outcomes

Brief summary

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.

Detailed description

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: * Reproductive outcomes: pregnancy rate, live birth rate (LBR) and abortion rate. * Obstetrical outcomes: twinning rate, gestational age, prematurity rate, birth weight, cesarean section rate and the rate of the main obstetrical complication, such as pre-eclampsia, gestational hypertension, intrauterine growth restriction (IUGR).

Interventions

PROCEDUREICSI-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.

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for obstructive azoospermia group: * infertility * diagnosis of obstructive azoospermia * ICSI-TESE cycles Inclusion Criteria for non-obstructive azoospermia group: * infertility * diagnosis of non-obstructive azoospermia * ICSI-TESE cycles

Exclusion criteria

* Sperm donation * Use of ejaculated sperm * Couples who underwent pre-implantation genetic testing

Design outcomes

Primary

MeasureTime frameDescription
Live birth rate (LBR)20 years (2001-2019)Rate of delivery of a living baby after at least 22 weeks of gestation
Pregnancy rate20 years (2001-2019)Total number of pregnancies including live births, abortions and fetal death
Abortion rate20 years (2001-2019)Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
Maternal complications rate20 years (2001-2019)Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension, placenta previa and placental abruption, intrauterine growth restriction.
Gestational age20 years (2001-2019)Mean gestational age of the pregnancies considered (written with both weeks and days)
Prematurity rate20 years (2001-2019)Rate of pregnancies lasted less than 37 weeks and 0 days
Twinning rate20 years (2001-2019)Rate of twin deliveries out of the total number of deliveries
Cesarean section rate20 years (2001-2019)Rate of cesarean section deliveries out of the total number of deliveries
Birth weight20 years (2001-2019)Mean birth weight of the neonates written in grams.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026