Double vs Single Intrauterine Insemination in Male Factor Infertility

Male Factor Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885516
• Other study ID #: B.10.1.TKH.4.34.H.GP.0.01/384
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: December 22, 2024

Study information

• Verified date: November 2023
• Source: Umraniye Education and Research Hospital
• Contact: Merve Dizdar, Speacialist
• Phone: +905355962232
• Email: mervedizdar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 22, 2024
• Est. primary completion date: November 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Male Factor Infertility

Intervention

Procedure:
• intrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter

Locations

Country	Name	City	State
Turkey	Umraniye Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical pregnancy	Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography	Within 4-6 weeks after insemination
Secondary	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