AZOOCOMES: Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Reproductive outcomes: pregnancy rate, live birth rate (LBR) and abortion rate.
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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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ICSI-TESE cycles for obstructive azoospermia Couples who underwent ICSI-TESE cycles for obstructive 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.
|
| ICSI-TESE cycles for nonobstructive azoospermia 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.
|
Outcome Measures
Primary Outcome Measures
- Live birth rate (LBR) [20 years (2001-2019)]
Rate of delivery of a living baby after at least 22 weeks of gestation
- Pregnancy rate [20 years (2001-2019)]
Total number of pregnancies including live births, abortions and fetal death
- Abortion rate [20 years (2001-2019)]
Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
- Maternal complications rate [20 years (2001-2019)]
Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension, placenta previa and placental abruption, intrauterine growth restriction.
- Gestational age [20 years (2001-2019)]
Mean gestational age of the pregnancies considered (written with both weeks and days)
- Prematurity rate [20 years (2001-2019)]
Rate of pregnancies lasted less than 37 weeks and 0 days
- Twinning rate [20 years (2001-2019)]
Rate of twin deliveries out of the total number of deliveries
- Cesarean section rate [20 years (2001-2019)]
Rate of cesarean section deliveries out of the total number of deliveries
- Birth weight [20 years (2001-2019)]
Mean birth weight of the neonates written in grams.
Eligibility Criteria
Criteria
Inclusion Criteria for obstructive azoospermia group:
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infertility
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diagnosis of obstructive azoospermia
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ICSI-TESE cycles
Inclusion Criteria for non-obstructive azoospermia group:
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infertility
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diagnosis of non-obstructive azoospermia
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ICSI-TESE cycles
Exclusion Criteria:
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Sperm donation
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Use of ejaculated sperm
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Couples who underwent pre-implantation genetic testing
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Istituto Clinico Humanitas
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Bocca S, Moussavi V, Brugh V, Morshedi M, Stadtmauer L, Oehninger S. ICSI outcomes in men undergoing TESE for azoospermia and impact of maternal age. Andrologia. 2017 Mar;49(2). doi: 10.1111/and.12617. Epub 2016 May 20.
- He X, Cao Y, Zhang Z, Zhao J, Wei Z, Zhou P, Cong L. Spermatogenesis affects the outcome of ICSI for azoospermic patients rather than sperm retrieval method. Syst Biol Reprod Med. 2010 Dec;56(6):457-64. doi: 10.3109/19396368.2010.513078. Epub 2010 Oct 14.
- La Sala GB, Valli B, Leoni S, Pescarini M, Martino F, Nicoli A. Testicular sperm aspiration (TESA) in 327 ICSI cycles. Int J Fertil Womens Med. 2006 Jul-Aug;51(4):177-82.
- Palermo GD, Schlegel PN, Hariprashad JJ, Ergün B, Mielnik A, Zaninovic N, Veeck LL, Rosenwaks Z. Fertilization and pregnancy outcome with intracytoplasmic sperm injection for azoospermic men. Hum Reprod. 1999 Mar;14(3):741-8.
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