Influence of Pb&Cd Seminal Plasma Level & ICSI
The Influence of Lead and Cadmium Seminal Plasma Level on Intracytoplasmic Sperm Injection (ICSI) Outcome
1 other identifier
observational
50
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 23, 2021
July 1, 2021
6 months
February 25, 2020
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
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: 19106447BACKGROUNDGill 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: 29594950BACKGROUNDWdowiak 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: 29936824BACKGROUNDKumar 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: 20529961BACKGROUNDKruger 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: 2946611BACKGROUNDTong 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
Condition Hierarchy (Ancestors)
Central Study Contacts
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