NCT04515134

Brief Summary

The aim of this study to assess the follicular fluid level of coenzyme Q10 in women undergoing intracytoplasmic sperm injection (ICSI) and its impact on pregnancy outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

August 13, 2020

Last Update Submit

May 16, 2022

Conditions

Pregnancy Outcome

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    clinical pregnancy rate following the intracytoplasmic sperm injection (ICSI) and its relation to follicular fluid coenzyme Q10.

    baseline

Secondary Outcomes (1)

  • implantation rate

    baseline

Interventions

assessment of follicular level of coenzyme Q10 in the ovaries in females undergoing ICSIDIAGNOSTIC_TEST

human coenzyme Q10 (CoQ10) ELISA kit

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This work will be conducted on normal and poor responder women undergoing ICSI procedure in ART unit in Obstetrics and Gynaecology department, South Valley University hospital female patient aged 20-42 years. poor responders have at least 2 of the following features: 1. advanced maternal age (40 years or more). 2. previous poor ovarian response (3 or less oocyte retrieved following stimulation). 3. abnormal ovarian reserve teseting (AFC 5-7 or AMH 0.5-1).

You may qualify if:

  • Patient age 20-42 years.
  • Normal and Poor responders women undergoing ICSI procedure.

You may not qualify if:

  • Hyper responder patients as polycystic ovarian syndrome (PCOs) patients.
  • Endocrine or metabolic diseases including hyperprolactinoma, hypothyroidism and hyperthyroidism, DM and adrenal disease
  • Patients with severe male factor or Y chromosome abnormality.
  • Patients with systemic disease such as chronic renal disease, chronic liver disease and systemic lupus disease.
  • patients with uterine cavity pathology or abnormality (endometrial polyp, myoma, hyperplasia, congenital abnormality) detected by trasvaginal 3-dimentional ultrasound or office hysteroscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Mohamed Atef

Alexandria, aAlexandria, 21515, Egypt

RECRUITING

Related Publications (4)

  • Akarsu S, Gode F, Isik AZ, Dikmen ZG, Tekindal MA. The association between coenzyme Q10 concentrations in follicular fluid with embryo morphokinetics and pregnancy rate in assisted reproductive techniques. J Assist Reprod Genet. 2017 May;34(5):599-605. doi: 10.1007/s10815-017-0882-x. Epub 2017 Feb 9.

    PMID: 28185121BACKGROUND

  • Ben-Meir A, Burstein E, Borrego-Alvarez A, Chong J, Wong E, Yavorska T, Naranian T, Chi M, Wang Y, Bentov Y, Alexis J, Meriano J, Sung HK, Gasser DL, Moley KH, Hekimi S, Casper RF, Jurisicova A. Coenzyme Q10 restores oocyte mitochondrial function and fertility during reproductive aging. Aging Cell. 2015 Oct;14(5):887-95. doi: 10.1111/acel.12368. Epub 2015 Jun 26.

    PMID: 26111777BACKGROUND

  • Bentov Y, Hannam T, Jurisicova A, Esfandiari N, Casper RF. Coenzyme Q10 Supplementation and Oocyte Aneuploidy in Women Undergoing IVF-ICSI Treatment. Clin Med Insights Reprod Health. 2014 Jun 8;8:31-6. doi: 10.4137/CMRH.S14681. eCollection 2014.

    PMID: 24987272BACKGROUND

  • Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.

    PMID: 21502182BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

follicular fluid of the ovary will be aspirated, centrifuged and assessed for coenzyme Q10

Study Officials

  • mahmoud s mowad, MD

    South Valley University

    STUDY CHAIR

Central Study Contacts

Mohamed Mohamed a Elzarka, MSCc

CONTACT

+201021164099mohamedelzarka@med.svu.edu.eg

Ahmed H Abdellah, professor MD

CONTACT

+201003438925ahmed.abdelah@med.svu.edu.eg

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

August 13, 2020

First Posted

August 17, 2020

Study Start

September 14, 2021

Primary Completion

August 5, 2022

Study Completion

September 10, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

EG(1)