Timing and Intrauterine Insemination in Unexplained Infertility

Study Overview
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Brief Summary
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to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .

Detailed Description
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IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.

Official Title
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Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study

Conditions
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Intrauterine Insemination

Intervention / Treatment
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* Drug: hCG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild male infertility or unexplained infertility Exclusion Criteria: Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women will be randomly divided in to four groups the first Group will undergo IUI after 24 H of hCG administration the second g will undergo IUI after 36 h after hCG the third Group will undergo IUI after 48h of hCG administration the last Group will undergo IUI at the time of hCG adminstration
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP 1<br>IUI 24 hours after hCGadminstration | Drug: hCG<br>* Women will be given hCG before or with IUI<br>* Other names: Pregnyl;|
| Active Comparator: GROUP 2<br>IUI 36 hours after hCG adminstration | Drug: hCG<br>* Women will be given hCG before or with IUI<br>* Other names: Pregnyl;|
| Active Comparator: GROUP 3<br>IUI 48 hours after hCG adminstration | Drug: hCG<br>* Women will be given hCG before or with IUI<br>* Other names: Pregnyl;|
| Active Comparator: GROUP 4<br>IUI at time of hCG adminstration | Drug: hCG<br>* Women will be given hCG before or with IUI<br>* Other names: Pregnyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome | Positive serum beta hCG test | 14 days after IUI | 
| Secondary outcome | Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan | 4 weeks after insemination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility