Is there a difference in pregnancy rates between Single Intrauterine Insemination (SIUI) and Double Intrauterine Insemination (DIUI) in couples with primary or secondary subfertility?

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 Professorial Unit of the Colombo North Teaching Hospital, Ragama. Out of the subfertile couples who are attending the subfertility clinic the patients who are suitable to undergo intrauterine insemination are selected under the supervision of the specialist Obstetrician and Gynaecologist.

a. Method of randomization into study arms will be by simple randomization. Couples who are selected through the inclusion and exclusion criteria will be enrolled to the study following informed written consent. On recruitment a random number (between 1- 206) will be generated from Microsoft Excel and given to the selected patients. This randomization will be done by a nurse who will be in no way involved in the study. If the number is even, they will be allocated to the DIUI arm and if it is an odd number, they will be allocated into the SIUI arm.

b. Unit of randomization will be the couple.

c. Method of sequence generation will be through computer generated random numbers using Microsoft Excel.

d. Method of allocation concealment is through generation of allocation sequences by the computer-generated random numbers and concealment of allocation sequences. The concealment of allocation sequences will be achieved by having nurse, who is not involved in the study generate the random numbers and handing it over in concealed envelopes. (Concealed envelope refers to an envelope which is non transparent and is sealed)

1. The intervention will be the double intrauterine insemination. The insemination will be done at 12 hours and 36 hours after the hCG injection. The hCG will be given at 9pm in and the IUIs will be done at 9am the following day and 9am the day after.

2. The control will be a single intrauterine insemination done at 36 hours following the hCG injection given at 9pm.

3. Following insemination the couple is allowed to go home. She is free to carry out her daily activities and no additional care is needed. A urine hCG test will be performed 3 weeks following the insemination procedure. If she has any fever, vaginal discharges or any other complaints during the 3 weeks, she is advised to come to hospital where she will be evaluated by a MBBS qualified doctor.

4. Control follows standard care. i.e Following insemination the couple is allowed to go home. She is free to carry out her daily activities and no additional care is needed. A urine hCG test will be performed 3 weeks following the insemination procedure. If she has any fever, vaginal discharges or any other complaints during the 3 weeks, she is advised to come to hospital where she will be evaluated by a MBBS qualified doctor.

5. Enrollment takes place at the time of seeing an 18mm size follicle, and randomization occurs at the same time. Since the hCG injection will be given on the same day at 9pm, it will be revealed at that moment whether the couple will be undergoing single or double intrauterine insemination. Therefore both the participants and the healthcare providers will know whether the couple is in the intervention or control group.

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

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