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Completed

NCT Number: NCT00675142

Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek Medical Center

Afula, 18101, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Intrauterine Insemination

Procedure

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

Primary outcomes

  1. Achieving pregnancy

    Time frame: 2 weeks after intervention

Secondary outcomes

  1. Live Birth

    Time frame: 9 months after interventio

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

A Randomized Open Three Arm Prospective Trial To Determine The Optimal Timing for Intrauterine Insemination After Superovulation With Recombinant Gonadotropins Utilizing GnRH Antagonists

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 8, 2008
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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