NCT00993902

Brief Summary

Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (\>16mm).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2008

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

Study Start

First participant enrolled

May 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

July 22, 2009

Last Update Submit

October 13, 2009

Conditions

Infertility

Keywords

Double IUIIntrauterine inseminationUnexplained infertility

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rates

    pregnancy >12 weeks of gestation

Secondary Outcomes (1)

  • The effects of different coh regimens on outcomes

    14 days after IUI procedure

Study Arms (2)

Single IUI

SHAM COMPARATOR

Single IUI will be carried on after 36-38 hours of HCG administration

Procedure: Intrauterine insemination (single)

Double IUI

ACTIVE COMPARATOR
Procedure: Double intrauterine insemination

Interventions

Intrauterine insemination (single)PROCEDURE

Single IUI after 36-38 hours of HCG

Also known as: Group I
Single IUI
Double intrauterine inseminationPROCEDURE

Double insemination after 18 and 40 hours of HCG administration.

Also known as: Grup II
Double IUI

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Unexplained and mild male factor infertile patients
  • Minimum 2 follicles \>16 mm at the day of HCG
  • First 3 cycles

You may not qualify if:

  • Basal FSH \>12 mIU/L
  • Total antral follicle count\<6
  • Severe male factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit

Adana, 01120, Turkey (Türkiye)

Location

Related Publications (1)

  • 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: 20457669DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Single Person

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2009

First Posted

October 14, 2009

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

TU(1)