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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Intrauterine Insemination


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IUI 36 hours after ovulation induction | Procedure: Intrauterine Insemination<br>* Changing the time span between ovulation induction and IUI during fertility treatment.<br>|
| Experimental: 2<br>IUI 42 hours after ovulation induction | Procedure: Intrauterine Insemination<br>* Changing the time span between ovulation induction and IUI during fertility treatment.<br>|
| Experimental: 3<br>IUI 48 hours after ovulation induction | Procedure: Intrauterine Insemination<br>* Changing the time span between ovulation induction and IUI during fertility treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving pregnancy |  | 2 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth |  | 9 months after interventio | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Intra-uterine insemination, ovarian stimulation