NCT01622023

Brief Summary

The aim of the present study is to prospectively evaluate whether performing an intra-uterine insemination 24 hours after the spontaneous LH peak may result in significantly higher ongoing pregnancy rates compared to 48 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
435

participants targeted

Target at P50-P75 for phase_4 pregnancy

Timeline
Completed

Started Oct 2010

Typical duration for phase_4 pregnancy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

March 27, 2012

Last Update Submit

April 17, 2019

Conditions

Pregnancy

Keywords

inseminationdonor spermnatural cycle

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    end of 2013 (up to 2 years)

Secondary Outcomes (1)

  • live birth rate

    end of 2013 (up to 2 years)

Study Arms (2)

Study group

EXPERIMENTAL

intrauterine insemination after 24 hours

Procedure: intra-uterine insemination

Control group

ACTIVE COMPARATOR

intrauterine insemination after 48 hours

Procedure: intra-uterine insemination

Interventions

intra-uterine inseminationPROCEDURE

Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.

Also known as: no other interventions
Control groupStudy group

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • below 39 years of age on the day of LH peak
  • donor semen
  • natural cycle (without CC)
  • cycle with less than 3 follicles reaching 15 mm of diameter or more.
  • with basal hormonal values of progesterone ( \< 1,2 ng/dl)

You may not qualify if:

  • The patients excluded are women
  • who underwent more than 6 intrauterine inseminations,
  • with tubal infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christophe Blockeel

Brussels, 1090, Belgium

Location

Related Publications (1)

  • Blockeel C, Knez J, Polyzos NP, De Vos M, Camus M, Tournaye H. Should an intrauterine insemination with donor semen be performed 1 or 2 days after the spontaneous LH rise? A prospective RCT. Hum Reprod. 2014 Apr;29(4):697-703. doi: 10.1093/humrep/deu022. Epub 2014 Feb 18.

    PMID: 24549212DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 27, 2012

First Posted

June 18, 2012

Study Start

October 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

BE(1)