Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility

Study Overview
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Brief Summary
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A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

Detailed Description
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A prospective randomized study included 210 patients with Unexplained infertility subjected to coupled ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.

Official Title
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The Impact of Uterine Flushing With Human Chorionic Gonadotrophin Before Intrauterine Insemination on Pregnancy and Live Birth Rates in Women With Unexplained Infertility: A Randomized Controlled Trial

Conditions
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Unexplained Infertility

Intervention / Treatment
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* Procedure: HCG Uterine flushing
* Procedure: IUI
* Procedure: Vaginal flushing with 10 ml normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unexplained infertility (UI) Exclusion Criteria: body mass index (BMI) ≥35 kg/m2, Follicle Stimulating Hormone >10 International Unit /Litter in early follicular phase, diagnosed cause of infertility, menstrual cycle irregularity, ovarian cysts, sever cervical stenosis, former IUI, ongoing pregnancy and renal or hepatic diseases were all the exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HCG uterine flushing group<br>Uterine flushing was done one day before Intrauterine insemination (IUI) with HCG (500 IU) in 10 ml of saline followed by Intrauterine insemination (IUI). | Procedure: HCG Uterine flushing<br>* HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.<br>Procedure: IUI<br>* Intrauterine insemination (IUI)<br>|
| Placebo Comparator: IUI alone group<br>Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline | Procedure: IUI<br>* Intrauterine insemination (IUI)<br>Procedure: Vaginal flushing with 10 ml normal saline<br>* Flushing of the vagina with 10 ml of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth | Defined as pregnancies maintained beyond 20 weeks of gestation | 10 months of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemical pregnancy | Defined as positive serum pregnancy test | One month after randomization | 
| Clinical pregnancy | Defined by the presence of gestational sac with fetal heartbeats on ultrasound scan or histological identification of trophoblastic tissue. | Two months after randomization | 
| Adverse effects | Nausea, vomiting, and pain | one hour of the procedure |