AzTrials
AzTrials

Obstructive AzoospermiaNCT04852237

Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes?

An observational study of Obstructive Azoospermia and Obstetric Complication, run by Istituto Clinico Humanitas.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this study is to determine if the lack of exposure to sperm antigens is associated with worse maternal and neonatal outcomes in pregnancies obtained after ICSI (intracytoplasmic sperm injection)-TESE (testicular sperm extraction) for obstructive azoospermia. Read more about this study

Who is it for?
Ages 18 to 43 years
How many people
400 participants
Where
No sites listed yet
Study dates
1 Jan 2010to 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 to 43 years
  • All sexes
  • Adult

Study population: The study database will include all the pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia. A comparison of maternal and neonatal outcomes will be performed among the above-mentioned pregnancies and pregnancies from ICSI cycles with ejaculated sperm of couples with different indications occurred in the same period of time. The controls will be matched to the cases for the principal risk factors for adverse maternal and neonatal outcomes (maternal age, BMI) with a ratio of 1:2.

Who may be able to join

  • primary infertility
  • diagnosis of obstructive azoospermia
  • ICSI-TESE cycles
  • primary infertility
  • ICSI cycles with sperm from ejaculate

Who cannot join

  • pre-gestational hypertension
  • pre-gestational diabetes

About this study

Official title: Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes? A 10 Years Single-center Experience Comparing ICSI-TESE Pregnancies From ICSI Pregnancies

The objective of this study is to determine if the lack of exposure to sperm antigens is associated with worse maternal and neonatal outcomes in pregnancies obtained after ICSI (intracytoplasmic sperm injection)-TESE (testicular sperm extraction) for obstructive azoospermia.

The primary outcomes that will be investigated include:

  • Maternal outcomes: live birth rate (LBR), abortion rate, and the rate of the main obstetrics complication, such as pre-eclampsia, gestational hypertension and diabetes mellitus.
  • Neonatal outcomes: gestational age, prematurity rate, birth weight, sex ratio, 1- and 5-min APGAR, birth defects.
Read the detailed description

Several studies investigated the role of paternal factors in the development of preeclampsia; in particular, they analyzed the correlation between the vaginal exposure to male partner's semen and the incidence of preeclampsia, observing both a reduced risk of preeclampsia after prolonged exposure to the paternal seminal fluid and a higher incidence of preeclampsia in pregnancies conceived with a new father or with sperm donor. This leads to the hypothesis of an immunological role for sperm in inducing a mucosal immune tolerance-like status at the level of the uterus that could be critical in the subsequent implantation.

Previous studies also examined the neonatal outcomes from pregnancies obtained from surgically retrieved sperm, either epididymal or testicular sperm, and underlined that there is not overall increased risk in neonatal outcomes.

Our study aims at having a complete view on paternal, maternal and neonatal information and a follow up, that allows to correct possible confounders and to analyze a wider group of outcomes.

Keywords
Neonatal outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04852237
Study groupRoleWhat they receive
Pregnancies from ICSI-TESE cycles for obstructive azoospermia.Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia.
Pregnancies from ICSI cycles with ejaculated sperm.Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI cycles with ejaculated sperm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth rate (LBR)

    Rate of delivery of a living baby after at least 22 weeks of gestation

    Measured: 10 years

  2. Abortion Rate (AR)

    Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation

    Measured: 10 years

  3. Maternal complications rate

    Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension and diabetes, placenta previa and placental abruption.

    Measured: 10 years

  4. Gestational age

    Mean gestational age of the pregnancies considered (written with both weeks and days; eg, 39 weeks and 0 days)

    Measured: 10 years

  5. Prematurity rate

    Rate of pregnancies lasted less than 37 weeks and 0 days

    Measured: 10 years

  6. Birth weight

    Mean birth weight of the neonates, written in grams.

    Measured: 10 years

  7. Sex ratio

    Ratio between males and females among the newborns

    Measured: 10 years

  8. 1- and 5-min APGAR

    Objective score of the condition of a baby after birth, at 1 and 5 minutes from the delivery (from 1 to 10 points).

    Measured: 10 years

  9. Incidence of congenital defects

    Incidence of congenital malformations, deformations and chromosomal abnormalities among the newborns of the study group (eg. clubfoot deformity, anorectal malformations, heart defects, ...)

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start1 Jan 2010
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

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
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04852237
Sponsor's protocol ID
1916
Status last verified
Apr 2021
First submitted
30 Mar 2021
Last updated
22 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Robertson SA, Sharkey DJ. Seminal fluid and fertility in women. Fertil Steril. 2016 Sep 1;106(3):511-9. doi: 10.1016/j.fertnstert.2016.07.1101. Epub 2016 Jul 30.

    PubMed 27485480

  • Verwoerd GR, Hall DR, Grove D, Maritz JS, Odendaal HJ. Primipaternity and duration of exposure to sperm antigens as risk factors for pre-eclampsia. Int J Gynaecol Obstet. 2002 Aug;78(2):121-6. doi: 10.1016/s0020-7292(02)00130-3.

    PubMed 12175712

  • Wang JX, Knottnerus AM, Schuit G, Norman RJ, Chan A, Dekker GA. Surgically obtained sperm, and risk of gestational hypertension and pre-eclampsia. Lancet. 2002 Feb 23;359(9307):673-4. doi: 10.1016/S0140-6736(02)07804-2.

    PubMed 11879865

  • Di Mascio D, Saccone G, Bellussi F, Vitagliano A, Berghella V. Type of paternal sperm exposure before pregnancy and the risk of preeclampsia: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2020 Aug;251:246-253. doi: 10.1016/j.ejogrb.2020.05.065. Epub 2020 Jun 1.

    PubMed 32544753

  • Dekker G, Robillard PY, Roberts C. The etiology of preeclampsia: the role of the father. J Reprod Immunol. 2011 May;89(2):126-32. doi: 10.1016/j.jri.2010.12.010. Epub 2011 May 6.

    PubMed 21529966

  • Andraweera P, Roberts CT, Leemaqz S, McCowan L, Myers J, Kenny LC, Walker J, Poston L, Dekker G; SCOPE Consortium. The duration of sexual relationship and its effects on adverse pregnancy outcomes. J Reprod Immunol. 2018 Aug;128:16-22. doi: 10.1016/j.jri.2018.05.007. Epub 2018 May 18.

    PubMed 29803191

  • Klonoff-Cohen HS, Savitz DA, Cefalo RC, McCann MF. An epidemiologic study of contraception and preeclampsia. JAMA. 1989 Dec 8;262(22):3143-7.

    PubMed 2810672

  • Robillard PY, Dekker G, Chaouat G, Hulsey TC, Saftlas A. Epidemiological studies on primipaternity and immunology in preeclampsia--a statement after twelve years of workshops. J Reprod Immunol. 2011 May;89(2):104-17. doi: 10.1016/j.jri.2011.02.003. Epub 2011 May 4.

    PubMed 21543120

  • Jin L, Li Z, Gu L, Huang B. Neonatal outcome of children born after ICSI with epididymal or testicular sperm: A 10-year study in China. Sci Rep. 2020 Mar 20;10(1):5145. doi: 10.1038/s41598-020-62102-y.

    PubMed 32198466

  • Belva F, De Schrijver F, Tournaye H, Liebaers I, Devroey P, Haentjens P, Bonduelle M. Neonatal outcome of 724 children born after ICSI using non-ejaculated sperm. Hum Reprod. 2011 Jul;26(7):1752-8. doi: 10.1093/humrep/der121. Epub 2011 Apr 21.

    PubMed 21511713

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Azoospermia and Obstetric Complication, 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 5 inclusion and 2 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 22 Apr 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: 10 years). 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 NCT04852237, which also lists 10 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 22 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in