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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Intrauterine Insemination

• Registration Number: NCT00675142
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intrauterine Insemination	IUI 36 hours after ovulation induction
2	Intrauterine Insemination	IUI 42 hours after ovulation induction
3	Intrauterine Insemination	IUI 48 hours after ovulation induction

Primary Outcome Measures

Name	Time	Method
Achieving pregnancy	2 weeks after intervention

Secondary Outcome Measures

Name	Time	Method
Live Birth	9 months after interventio

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel