Clinical trial NCT05885516: Double vs Single Intrauterine Insemination in Male Factor Infertility
Official title: Double vs Single Intrauterine Insemination in Male Factor Infertility - a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Male Factor Infertility
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-02
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of clinical pregnancy
timeFrame: Within 4-6 weeks after insemination
Secondary outcomes:
measure: Rate of biochemical, ectopic pregnancies and rate of miscarriages
timeFrame: Within 3 months after insemination
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Training and Research Hospital
Study officials:
References:
citation: Rakic L, Kostova E, Cohlen BJ, Cantineau AE. Double versus single intrauterine insemination (IUI) in stimulated cycles for subfertile couples. Cochrane Database Syst Rev. 2021 Jul 14;7(7):CD003854. doi: 10.1002/14651858.CD003854.pub2.
citation: Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.