NCT05628766

Brief Summary

The aim in this study is to determine whether there is a relationship between Thiol / Disulphide levels in primary infertile patients and comparing them with infertile patients and the control group. For this purpose, 41 women followed up with the diagnosis of primary infertility in Siirt Training and Research Hospital between November 2022 and January 2023 will be included in the study. The same number of (n:41) non-infertile control women will be included. Age, pregnancy history and medical history of both groups will be recorded. FSH, LH, E2, TSH, and prolactin levels taken routinely in these patients will be examined. Thiol/disulphide levels in the blood will be checked by taking whole blood from these patients. In the light of the information thus obtained, the investigator plan to determine whether there is a relationship between oxidant/antioxidant balance in primary infertile patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 7, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

November 7, 2022

Last Update Submit

April 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measuring the total oxidant/antioxidant load with the Thiol/disulfide method in patients with unexplained infertility

    To determine whether there is a relationship between oxidant/ antioxidant balance in primary infertile patients by looking at Thiol/disulphide blood levels in both groups.

    "through study completion, an average of 4 months

Study Arms (2)

Women diagnosed with primary infertility (n:41)

Women which followed up with infertility of unknown cause.

Other: complete blood count

Control group ( n:41)

Healthy women who are not infertile

Other: complete blood count

Interventions

Thiol/disulphide levels in the blood will be checked by taking complete blood count

Control group ( n:41)Women diagnosed with primary infertility (n:41)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women between the age of 18-35 diagnosed with infertility of unknown cause.

You may qualify if:

  • Patients diagnosed with primary infertility
  • Patients between the age of 18-35

You may not qualify if:

  • Active hypertension
  • Chronic liver or kidney failure history
  • Coronary artery disease
  • Acute infection (within 14 days)
  • Any chronic inflammatory disease
  • Presence of autoimmune disease
  • Known malignancy
  • Inflammatory bowel disease
  • Hormonal contraception
  • Smoking
  • alcohol use
  • Drug use
  • Patients with tubal infertility
  • Partner with abnormal spermiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Üniversity Medical Faculty

Siirt, 56000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Şerif Aksin, assoc.Prof

    Siirt University Medical Faculty Obstetrics and Gynecology Departmant

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 29, 2022

Study Start

November 30, 2022

Primary Completion

April 21, 2023

Study Completion

April 21, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations