NCT04286633

Brief Summary

To evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (ICSI).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

February 25, 2020

Last Update Submit

July 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The influence of lead and cadmium seminal plasma level on intracytoplasmic sperm injection (ICSI) outcome

    evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (ICSI).

    baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

prospective cohort study to evaluate seminal plasma lead and cadmium level affects intracytoplasmic sperm injection out come

You may qualify if:

  • Isolated male infertility (oligozoospermia, astenozoospermia, teratozoospermia)
  • First ICSI cycle
  • Female partner ≤ 35 y-old

You may not qualify if:

  • Wife age \> 35 years
  • Frozen semen samples
  • Male partner with severe oligoasthenoteratozoospermia \<5 × 106 / mL and 5% progressive motility, included globozoospermia and pinhead samples, and surgically retrieved sperms
  • Poor responder women
  • Women with abnormal endometrium at hCG trigger day.
  • Women with BMI \> 31
  • Women with PCOS
  • Previous failed ICSI
  • OHSS)overian hyperstimulation syndrome)
  • Patients with systemic diseases affecting fertility
  • Patients on radiotherapy or receiving medications with gonadotoxic effect eg., chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Bernard A. Cadmium & its adverse effects on human health. Indian J Med Res. 2008 Oct;128(4):557-64.

    PMID: 19106447BACKGROUND
  • Gill K, Rosiak A, Gaczarzewicz D, Jakubik J, Kurzawa R, Kazienko A, Rymaszewska A, Laszczynska M, Grochans E, Piasecka M. The effect of human sperm chromatin maturity on ICSI outcomes. Hum Cell. 2018 Jul;31(3):220-231. doi: 10.1007/s13577-018-0203-4. Epub 2018 Mar 29.

    PMID: 29594950BACKGROUND
  • Wdowiak A, Wdowiak E, Bojar I. Evaluation of trace metals in follicular fluid in ICSI-treated patients. Ann Agric Environ Med. 2017 Jun 23;25(2):213-218. doi: 10.26444/aaem/75422. Epub 2017 Jun 23.

    PMID: 29936824BACKGROUND
  • Kumar S, Mishra VV. Review: Toxicants in reproductive fluid and in vitro fertilization (IVF) outcome. Toxicol Ind Health. 2010 Sep;26(8):505-11. doi: 10.1177/0748233710373081. Epub 2010 Jun 7.

    PMID: 20529961BACKGROUND
  • Kruger TF, Menkveld R, Stander FS, Lombard CJ, Van der Merwe JP, van Zyl JA, Smith K. Sperm morphologic features as a prognostic factor in in vitro fertilization. Fertil Steril. 1986 Dec;46(6):1118-23. doi: 10.1016/s0015-0282(16)49891-2.

    PMID: 2946611BACKGROUND
  • Tong S, Von Schirnding YE, Prapamontol T. [Environmental lead exposure: a public health problem with global dimensions]. Servir. 2000 Jan-Feb;49(1):35-43. No abstract available. Portuguese.

    PMID: 12029976BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Central Study Contacts

Shaimaa Abdul-Rahman, master student

CONTACT

Ali Mahran, professor doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

May 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

July 23, 2021

Record last verified: 2021-07