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

HaEmek Medical Center, Israel

Status: Completed

Conditions: Infertility

Treatments: Procedure: Intrauterine Insemination

Study type: Interventional

Funder types: Other

Identifiers

NCT00675142

5-08EMC.CTIL

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 3 patient groups

1

Experimental group

Description:

IUI 36 hours after ovulation induction

Treatment:

Procedure: Intrauterine Insemination

2

Experimental group

Description:

IUI 42 hours after ovulation induction

Treatment:

Procedure: Intrauterine Insemination

3

Experimental group

Description:

IUI 48 hours after ovulation induction

Treatment:

Procedure: Intrauterine Insemination