Timing and Intrauterine Insemination in Unexplained Infertility

Phase 4

• Conditions: Intrauterine Insemination
• Interventions: Drug: hCG

• Registration Number: NCT03920514
• Lead Sponsor: Sohag University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-19
• Last Update Posted: 2019-04-19
• Study Start: 2019-04-30
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP 1	hCG	IUI 24 hours after hCGadminstration
GROUP 2	hCG	IUI 36 hours after hCG adminstration
GROUP 3	hCG	IUI 48 hours after hCG adminstration
GROUP 4	hCG	IUI at time of hCG adminstration

Primary Outcome Measures

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