Randomized Controlled Trial on single intrauterine insemination vs double intrauterine insemination to compare the pregnancy rates among couples attending an infertility clinic in Sri Lanka

Not Applicable

Conditions: Subfertility

Registration Number: SLCTR/2022/024

Lead Sponsor: Dr. DInindu Priyadarshana Kaluarachchi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 206

Inclusion Criteria

a.Married Women between 20-40 years of age
b.Women who undergo ovulation induction and with a Leading follicular size of 18mm or more in transvaginal ultrasound scan (TVS)
c.Couples that present with primary or secondary subfertility for over one year period
d.Women who have confirmed tubal patency of at least one tube by laparoscopy and/ or hysterosalpingography
e.Men with normal parameters according to WHO criteria or with mild male factor infertility in the Seminal Fluid Analysis (SFA), which has been done within 3 months of recruitment into the study

Exclusion Criteria

a.Women with anatomical defects of the female reproductive tract
b.Moderate to severe male factor infertility on SFA according to WHO criteria
c.Patients who did not respond to ovulation induction
d.If there are more than 6 follicles with a diameter of 14mm or more
e.Patients who have unilateral tubal patency and a dominant follicle developed on the contralateral side
f.Patients with active pelvic infection or a vaginal infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arms will be compared using the pregnancy rate. <br>Pregnancy rate in this context will be;<br>(The number of pregnancies that have been confirmed by both urine hCG and ultrasound criteria ÷ Number of IUI cycles) x 100%<br><br>Pregnancy rates in both arms will be calculated and compared for any statistically significant difference<br>A positive pregnancy confirmed by an Ultrasound scan with the following criteria.<br>Intrauterine pregnancy<br>which will be performed 3 weeks after the following criteria are met.<br><br>- Missed period<br>- Positive urine hCG<br>- Rising serum beta HCG 48 hours apart<br>If initial urine hCG was negative, a repeat urine hCG will be done 25 days following the insemination to confirm that there is no pregnancy.<br> [Initial measurement done at day 18 post IUI ]<br>

Secondary Outcome Measures