Double vs Single Intrauterine Insemination in Male Factor Infertility

Study Overview
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Brief Summary
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The aim of the study is to compare the pregnancy outcomes of single vs double intrauterine insemination (IUI) in couples with male factor infertility.

Detailed Description
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The principle behind double intrauterine insemination in male factor infertility couples is to create a longer time frame for fertilization and to increase motile sperm number in female genital tract in order to increase pregnancy rates. There's a clinical equipoise on the benefits of performing double IUI in couples following ovarian hyperstimulation with daily follicle stimulating hormone injections in male factor subfertility. As it is stated in Cochrane database, there's a need for adequately powered, randomized, high-quality studies on this subject. In this study, as a result of a-priori power analysis 132 participants in each study arm is planned to be recruited in the study. Male factor infertility included in the study is defined as total motile sperm count (TPMSC) less than 10 million. TPMSC less than 1 million, female age greater than 40, uterine anomaly, no patent tubes shown in hysterosalpingography, history of ovarian surgery and known endometriosis will be excluded. Couples with two basal semen analysis with TPMSC between 1-10 million will be randomized to single or double IUI procedure. To accomplish this in approximately 1 year period, the study is planned as a multi-center study. The objective of the study is to compare the pregnancy outcomes of single and double intrauterine insemination groups, following ovarian hyperstimulation in couples with male factor subfertility.

Official Title
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Double vs Single Intrauterine Insemination in Male Factor Infertility - a Multicenter Randomized Trial

Conditions
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Male Factor Infertility

Intervention / Treatment
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* Procedure: intrauterine insemination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples trying to conceive for at least 6 months despite of regular sexual intercourse Female partner between 18-40 years old Male partner sperm analysis total motile sperm count between 1-10 million in at least 2 sperm analysis on different days. Exclusion Criteria: No patent fallopian tubes shown in hystero-salpingography Female partner with a uterine anomaly History of a previous ovarian surgery Known or suspected endometriosis in female partner Body-mass index (BMI) > 40 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Single intrauterine insemination group<br>When the leading follicle is greater than 17 mm following ovulation induction with follicle stimulating hormone (FSH) daily injections, ovulation trigger injection will be given to the participant. 36 hours after ovulation trigger injection single intrauterine insemination with partner's sperm collected on the same day will be done. | Procedure: intrauterine insemination<br>* Giving washed sperm concentrate into uterine cavity via a soft catheter<br>|
| Experimental: Double intrauterine insemination group<br>When the leading follicle is greater than 17 mm following ovulation induction with follicle stimulating hormone (FSH) daily injections, ovulation trigger injection will be given to the participant. 24 and 48 hours after ovulation trigger injection intrauterine insemination will be done twice with partner's sperm collected on the specified days. | Procedure: intrauterine insemination<br>* Giving washed sperm concentrate into uterine cavity via a soft catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical pregnancy | Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography | Within 4-6 weeks after insemination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of biochemical, ectopic pregnancies and rate of miscarriages | Pregnancy outcomes including biochemical, ectopic pregnancies and miscarriages diagnosed by transvaginal ultrasonography | Within 3 months after insemination |