NCT00675142

Brief Summary

The timing of IUI following ovulation induction has been the subject of many studies and a consensus has developed that a single insemination approximately thirty-six hours after ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature LH surge and early ovulation has added a new dimension to fertility treatment. It allows greater accuracy in predicting the timing of ovulation and has been shown to be at least as effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released from the ovary. We therefore propose a randomized open three arm prospective trial utilizing superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48 hours after ovulation induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

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
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

3.3 years

First QC Date

May 7, 2008

Last Update Submit

June 21, 2015

Conditions

Infertility

Keywords

InfertilityIntra-uterine inseminationovarian stimulation

Outcome Measures

Primary Outcomes (1)

  • Achieving pregnancy

    2 weeks after intervention

Secondary Outcomes (1)

  • Live Birth

    9 months after interventio

Study Arms (3)

1

EXPERIMENTAL

IUI 36 hours after ovulation induction

Procedure: Intrauterine Insemination

2

EXPERIMENTAL

IUI 42 hours after ovulation induction

Procedure: Intrauterine Insemination

3

EXPERIMENTAL

IUI 48 hours after ovulation induction

Procedure: Intrauterine Insemination

Interventions

Intrauterine InseminationPROCEDURE

Changing the time span between ovulation induction and IUI during fertility treatment.

123

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with
  • Ovulatory disorder
  • male factor
  • partial mechanical factor
  • endometriosis
  • unexplained infertility.

You may not qualify if:

  • Known allergy to one or more of the utilized drugs
  • Neither fallopian tube is patent
  • Sperm count less than 1 million total motile sperm of normal morphology during at least two investigations
  • Women who are candidates for mono-ovulation.
  • failure to receive consent
  • women with baseline functional cysts (i.e. hormone producing) above 12 mm diameter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek Medical Center

Afula, 18101, Israel

Location

Related Publications (3)

  • Guzick DS. For now, one well-timed intrauterine insemination is the way to go. Fertil Steril. 2004 Jul;82(1):30-1; discussion 32-5. doi: 10.1016/j.fertnstert.2004.02.101.

    PMID: 15236983BACKGROUND

  • Guzick DS, Carson SA, Coutifaris C, Overstreet JW, Factor-Litvak P, Steinkampf MP, Hill JA, Mastroianni L, Buster JE, Nakajima ST, Vogel DL, Canfield RE. Efficacy of superovulation and intrauterine insemination in the treatment of infertility. National Cooperative Reproductive Medicine Network. N Engl J Med. 1999 Jan 21;340(3):177-83. doi: 10.1056/NEJM199901213400302.

    PMID: 9895397BACKGROUND

  • Gomez-Palomares JL, Julia B, Acevedo-Martin B, Martinez-Burgos M, Hernandez ER, Ricciarelli E. Timing ovulation for intrauterine insemination with a GnRH antagonist. Hum Reprod. 2005 Feb;20(2):368-72. doi: 10.1093/humrep/deh602. Epub 2004 Nov 26.

    PMID: 15567879BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Amir Weiss, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 8, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

IL(1)