Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Non-obstructive Azoospermia, Obstetric Complication, Obstructive Azoospermia

Intervention / Treatment
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* Procedure: ICSI-TESE; embryo-transfer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICSI-TESE cycles for obstructive azoospermia<br>Couples who underwent ICSI-TESE cycles for obstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center | Procedure: ICSI-TESE; embryo-transfer<br>* The sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer.<br>|
| ICSI-TESE cycles for nonobstructive azoospermia<br>Couples who underwent ICSI-TESE cycles for nonobstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center | Procedure: ICSI-TESE; embryo-transfer<br>* The sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate (LBR) | Rate of delivery of a living baby after at least 22 weeks of gestation | 20 years (2001-2019) | 
| Pregnancy rate | Total number of pregnancies including live births, abortions and fetal death | 20 years (2001-2019) | 
| Abortion rate | Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation | 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. | 20 years (2001-2019) | 
| Gestational age | Mean gestational age of the pregnancies considered (written with both weeks and days) | 20 years (2001-2019) | 
| Prematurity rate | Rate of pregnancies lasted less than 37 weeks and 0 days | 20 years (2001-2019) | 
| Twinning rate | Rate of twin deliveries out of the total number of deliveries | 20 years (2001-2019) | 
| Cesarean section rate | Rate of cesarean section deliveries out of the total number of deliveries | 20 years (2001-2019) | 
| Birth weight | Mean birth weight of the neonates written in grams. | 20 years (2001-2019) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reproductive outcomes