Obstructive AzoospermiaAZOOCOMESNCT04894136
Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia
An observational study of Obstructive Azoospermia and Non-obstructive Azoospermia, run by Istituto Clinico Humanitas.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Azoospermia, Non-obstructive Azoospermia, Obstetric Complication
- What is being tested?
- ICSI-TESE; embryo-transfer
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2001to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- infertility
- diagnosis of obstructive azoospermia
- ICSI-TESE cycles
- infertility
- diagnosis of non-obstructive azoospermia
- ICSI-TESE cycles
Who cannot join
- Sperm donation
- Use of ejaculated sperm
- Couples who underwent pre-implantation genetic testing
About this study
Official title: Reproductive and Obstetric Outcomes in TESE-ICSI Cycles: a Comparison Between Obstructive and Non-obstructive Azoospermia
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.
Read the 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).
- Being tested
- ICSI-TESE; embryo-transfer
- Keywords
- Reproductive outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSI-TESE; embryo-transferProcedure or surgery
The sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: ICSI-TESE; 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 Receives: Procedure: ICSI-TESE; embryo-transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate (LBR)
Rate of delivery of a living baby after at least 22 weeks of gestation
Measured: 20 years (2001-2019)
Pregnancy rate
Total number of pregnancies including live births, abortions and fetal death
Measured: 20 years (2001-2019)
Abortion rate
Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
Measured: 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.
Measured: 20 years (2001-2019)
Gestational age
Mean gestational age of the pregnancies considered (written with both weeks and days)
Measured: 20 years (2001-2019)
Prematurity rate
Rate of pregnancies lasted less than 37 weeks and 0 days
Measured: 20 years (2001-2019)
Twinning rate
Rate of twin deliveries out of the total number of deliveries
Measured: 20 years (2001-2019)
Cesarean section rate
Rate of cesarean section deliveries out of the total number of deliveries
Measured: 20 years (2001-2019)
Birth weight
Mean birth weight of the neonates written in grams.
Measured: 20 years (2001-2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jan 2001
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive AzoospermiaStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894136
- Sponsor's protocol ID
- 1906
- Acronym
- AZOOCOMES
- Status last verified
- Mar 2021
- First submitted
- 16 Apr 2021
- Last updated
- 20 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27198124He 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.
PubMed 20942727La 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.
PubMed 17184103Palermo GD, Schlegel PN, Hariprashad JJ, Ergun 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. doi: 10.1093/humrep/14.3.741.
PubMed 10221707
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive and Obstetric Outcomes in TESE-ICSI Cycles: a Comparison Between Obstructive and Non-obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT04894136
- Acronym / sponsor ID
- AZOOCOMES / 1906
- Keywords
- Reproductive outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2001 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI-TESE cycles for obstructive azoospermia | – | Procedure: ICSI-TESE; embryo-transferCouples who underwent ICSI-TESE cycles for obstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center |
| ICSI-TESE cycles for nonobstructive azoospermia | – | Procedure: ICSI-TESE; embryo-transferCouples who underwent ICSI-TESE cycles for nonobstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- infertility
- diagnosis of obstructive azoospermia
- ICSI-TESE cycles
- infertility
- diagnosis of non-obstructive azoospermia
Key exclusion criteria (3 listed)
- Sperm donation
- Use of ejaculated sperm
- Couples who underwent pre-implantation genetic testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICSI-TESE; embryo-transferThe sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer. | Procedure or surgery | ICSI-TESE cycles for nonobstructive azoospermia, ICSI-TESE cycles for obstructive azoospermia |
Primary outcome
Live birth rate (LBR)
Time frame: 20 years (2001-2019)
Rate of delivery of a living baby after at least 22 weeks of gestation
Pregnancy rate
Time frame: 20 years (2001-2019)
Total number of pregnancies including live births, abortions and fetal death
Abortion rate
Time frame: 20 years (2001-2019)
Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
Maternal complications rate
Time frame: 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
Time frame: 20 years (2001-2019)
Mean gestational age of the pregnancies considered (written with both weeks and days)
Prematurity rate
Time frame: 20 years (2001-2019)
Rate of pregnancies lasted less than 37 weeks and 0 days
Twinning rate
Time frame: 20 years (2001-2019)
Rate of twin deliveries out of the total number of deliveries
Cesarean section rate
Time frame: 20 years (2001-2019)
Rate of cesarean section deliveries out of the total number of deliveries
Birth weight
Time frame: 20 years (2001-2019)
Mean birth weight of the neonates written in grams.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Background: PubMed 27198124Bocca 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.
- Background: PubMed 20942727He 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.
- Background: PubMed 17184103La 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.
- Background: PubMed 10221707Palermo GD, Schlegel PN, Hariprashad JJ, Ergun 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. doi: 10.1093/humrep/14.3.741.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Azoospermia and Non-obstructive Azoospermia, run by Istituto Clinico Humanitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (LBR) (time frame: 20 years (2001-2019)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894136, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.