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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

Comparison of Single Intrauterine Insemination versus Double Intrauterine Insemination in infertility clinic in Sri Lanka: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2022/024
Enrollment
206
Registered
2022-10-20
Start date
2022-10-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility

Interventions

1. Study Setting will be Subfertility clinic at the Family Health Bureau, No: 231, De Saram Place, Colombo 10, Sri Lanka and the Subfertility clinic of the University Obstetrics and Gynaecology Profes

Sponsors

Dr. DInindu Priyadarshana Kaluarachchi
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Arms will be compared using the pregnancy rate. Pregnancy rate in this context will be; (The number of pregnancies that have been confirmed by both urine hCG and ultrasound criteria ÷ Number of IUI cycles) x 100% Pregnancy rates in both arms will be calculated and compared for any statistically significant difference A positive pregnancy confirmed by an Ultrasound scan with the following criteria. Intrauterine pregnancy which will be performed 3 weeks after the following criteria are met. - Missed period - Positive urine hCG - Rising serum beta HCG 48 hours apart 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. [Initial measurement done at day 18 post IUI ]

Secondary

MeasureTime frame
None []

Countries

Sri Lanka

Contacts

Public ContactDr. DInindu Priyadarshana Kaluarachchi

Registrar in Obstetrics and Gynaecology

dinindu.og87@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026