Male Factor InfertilityNCT05885516
Double vs Single Intrauterine Insemination in Male Factor Infertility
A study testing intrauterine insemination in people with Male Factor Infertility, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Male Factor Infertility
- What is being tested?
- intrauterine insemination
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 22 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Umraniye Training and Research Hospital
Istanbul
Merve Dizdar
About this study
Official title: Double vs Single Intrauterine Insemination in Male Factor Infertility - a Multicenter Randomized Trial
The aim of the study is to compare the pregnancy outcomes of single vs double intrauterine insemination (IUI) in couples with male factor infertility.
Read the 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.
- Conditions
- Male Factor Infertility
- Being tested
- intrauterine insemination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrauterine inseminationProcedure or surgery
Giving washed sperm concentrate into uterine cavity via a soft catheter
| Study group | Role | What they receive |
|---|---|---|
| Single intrauterine insemination group | Placebo comparator | 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. Receives: Procedure: intrauterine insemination |
| Double intrauterine insemination group | Experimental | 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. Receives: Procedure: intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical pregnancy
Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography
Measured: Within 4-6 weeks after insemination
Secondary outcomes (1)
Rate of biochemical, ectopic pregnancies and rate of miscarriages
Pregnancy outcomes including biochemical, ectopic pregnancies and miscarriages diagnosed by transvaginal ultrasonography
Measured: Within 3 months after insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start5 Jun 2023
- Primary completion22 Nov 2024 (estimated)
- Study completion22 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Male Factor InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merve Dizdar, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885516
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/384
- Status last verified
- Nov 2023
- First submitted
- 1 May 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34260059Bagis 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.
PubMed 20457669
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double vs Single Intrauterine Insemination in Male Factor Infertility - a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT05885516
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/384
- Conditions
- Male Factor Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 22 Nov 2024 (estimated)
- Study completion
- 22 Dec 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single intrauterine insemination group | Placebo comparator | Procedure: intrauterine inseminationWhen 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. |
| Double intrauterine insemination group | Experimental | Procedure: intrauterine inseminationWhen 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrauterine inseminationGiving washed sperm concentrate into uterine cavity via a soft catheter | Procedure or surgery | Double intrauterine insemination group, Single intrauterine insemination group |
Primary outcome
Rate of clinical pregnancy
Time frame: Within 4-6 weeks after insemination
Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography
1 secondary outcome
Rate of biochemical, ectopic pregnancies and rate of miscarriages
Time frame: Within 3 months after insemination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 34260059Rakic 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.
- Background: PubMed 20457669Bagis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrauterine insemination in people with Male Factor Infertility, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Dizdar, Speacialist (+905355962232, mervedizdar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical pregnancy (time frame: Within 4-6 weeks after insemination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885516, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.