Double vs Single Intrauterine Insemination in Male Factor Infertility
NCT ID: NCT05885516
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
264 participants
INTERVENTIONAL
2023-06-05
2024-12-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Single intrauterine insemination group
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.
intrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter
Double intrauterine insemination group
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.
intrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter
Interventions
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intrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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Umraniye Education and Research Hospital
OTHER_GOV
Responsible Party
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Merve Dizdar
Principal Investigator
Locations
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Umraniye Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Merve Dizdar
Role: primary
References
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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.
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.
Other Identifiers
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B.10.1.TKH.4.34.H.GP.0.01/384
Identifier Type: -
Identifier Source: org_study_id