NCT05885516

Brief Summary

The aim of the study is to compare the pregnancy outcomes of single vs double intrauterine insemination (IUI) in couples with male factor infertility.

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
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

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

May 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

May 1, 2023

Last Update Submit

November 28, 2023

Conditions

Male Factor Infertility

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical pregnancy

    Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography

    Within 4-6 weeks after insemination

Secondary Outcomes (1)

  • Rate of biochemical, ectopic pregnancies and rate of miscarriages

    Within 3 months after insemination

Study Arms (2)

Single intrauterine insemination group

PLACEBO COMPARATOR

When the leading follicle is greater than 17 mm following ovulation induction with follicle stimulating hormone (FSH) daily injections, ovulation trigger injection will be given to the participant. 36 hours after ovulation trigger injection single intrauterine insemination with partner's sperm collected on the same day will be done.

Procedure: intrauterine insemination

Double intrauterine insemination group

EXPERIMENTAL

When the leading follicle is greater than 17 mm following ovulation induction with follicle stimulating hormone (FSH) daily injections, ovulation trigger injection will be given to the participant. 24 and 48 hours after ovulation trigger injection intrauterine insemination will be done twice with partner's sperm collected on the specified days.

Procedure: intrauterine insemination

Interventions

intrauterine inseminationPROCEDURE

Giving washed sperm concentrate into uterine cavity via a soft catheter

Double intrauterine insemination groupSingle intrauterine insemination group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is not based on self-representation of gender identity. Participants should have a uterus with at least one patent fallopian tube and an internal os to achieve intrauterine insemination.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Couples trying to conceive for at least 6 months despite of regular sexual intercourse
  • Female partner between 18-40 years old
  • Male partner sperm analysis total motile sperm count between 1-10 million in at least 2 sperm analysis on different days.

You may not qualify if:

  • No patent fallopian tubes shown in hystero-salpingography
  • Female partner with a uterine anomaly
  • History of a previous ovarian surgery
  • Known or suspected endometriosis in female partner
  • Body-mass index (BMI) \> 40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Rakic L, Kostova E, Cohlen BJ, Cantineau AE. Double versus single intrauterine insemination (IUI) in stimulated cycles for subfertile couples. Cochrane Database Syst Rev. 2021 Jul 14;7(7):CD003854. doi: 10.1002/14651858.CD003854.pub2.

    PMID: 34260059BACKGROUND

  • Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.

    PMID: 20457669BACKGROUND

Central Study Contacts

Merve Dizdar, Speacialist

CONTACT

+905355962232mervedizdar@gmail.com

Gürkan Bozdağ, Professor

CONTACT

+905327136326gbozdag75@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2023

First Posted

June 2, 2023

Study Start

June 5, 2023

Primary Completion

November 22, 2024

Study Completion

December 22, 2024

Last Updated

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)