Double vs Single Intrauterine Insemination in Male Factor Infertility

Umraniye Education and Research Hospital

Status: Enrolling

Conditions: Male Factor Infertility

Treatments: Procedure: intrauterine insemination

Study type: Interventional

Funder types: Other

Identifiers

NCT05885516

B.10.1.TKH.4.34.H.GP.0.01/384

Details and patient eligibility

About

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

Full description

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.

Enrollment: 264 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 2 patient groups, including a placebo group

Single intrauterine insemination group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: intrauterine insemination

Double intrauterine insemination group

Experimental group

Description:

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.

Treatment:

Procedure: intrauterine insemination