InfertilityNCT03006523
0.2 ml vs. 0.5 Inseminated Volume in Donor Intrauterine Insemination Cycles: A Prospective RCT
A study testing Intrauterine insemination in people with Infertility and Infertility, Male, run by Fundacion Dexeus.
Trial summary
To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It is hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher clinical pregnancy rates will be achieved by promoting higher sperm densities in the fallopian tubes at the time of ovulation by decreasing… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Infertility, Male, Same-Sex Marriage
- What is being tested?
- Intrauterine insemination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Nov 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- All patients will undergo a full infertility investigation including hormonal evaluation between day 2 and day 5 of the cycle and confirmation of patency of the Fallopian tubes.
- Patients eligible for the study are between 18 and 40 years old and with regular menstrual cycles (21 - 35 days). Indications for the use of donor sperm are severe male factor infertility requiring donor sperm, the presence of a heritable genetic disorder in the male partner, a single-parent request or same-sex couples' partners undergoing IUI.
- Exclusion criteria are the presence of tubal factor infertility, grade III-IV endometriosis, more than 3 previous failed dIUI cycles, or patients in whom ≥3 follicles >14mm are observed during the IUI cycle. Patients will be included in the study only once. The randomization will be performed on the IUI cycle level. The group allocation will take place the day the dIUI and the biologist will randomized all included patients into one of the two groups using an open computer-generated list.
Who cannot join
None listed.
About this study
Official title: Impact of Inseminated Volume and Live Birth Rates After Intrauterine Insemination (IUI) With Donor Sperm (dIUI): A Prospective Randomized COntrolled Trial
To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It is hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher clinical pregnancy rates will be achieved by promoting higher sperm densities in the fallopian tubes at the time of ovulation by decreasing the amount of sperm cells lost during preparation and handling.
Read the detailed description
A prospective RCT will be performed, including patients undergoing dIUI under ovulation induction. The trial is established to compare two inseminated volumes, 0.2 ml (control group) and 0.5 mL (study group), and will be conducted at the Reproductive Medicine Service of the Dexeus Women's Health Center. The Institutional Review Board has approved the research project and an informed consent will be obtained from all patients participating to the study.
All patients will undergo a full infertility investigation including hormonal evaluation between day 2 and day 5 of the cycle and confirmation of patency of the Fallopian tubes. Patients eligible for the study are between 18 and 40 years old, with regular menstrual cycles (21 - 35 days). Indications for the use of donor sperm are male factor infertility due to azoospermia or severe oligoasthenoteratozoospermia (requiring donor sperm), the presence of a heritable genetic disorder in the male partner, a single-parent request or same-sex couples' partners undergoing IUI. Exclusion criteria are the presence of tubal factor infertility, ≥grade III endometriosis, more than 3 previous dIUI cycles, or patients in whom ≥3 follicles >14mm are observed during the cycle. The randomization procedure will take place the day the donor IUI procedure. The randomization will be performed on the IUI cycle level. Randomization into one of the two groups will be performed using an open computer-generated list.
IUI will be performed with a Wallace® catheter depositing 0.2 or 0.5 ml of the sperm sample at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 pm. After the procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day of the week, including weekends.
- Conditions
- Infertility, Infertility, Male, Same-Sex Marriage, Parent, Single
- Being tested
- Intrauterine insemination
- Keywords
- donor intrauterine insemination, insemination volume, Live Birth Rates, donor sperm
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine inseminationProcedure or surgery
IUI will be performed with a Wallace® insemination 2 Catheter (Cooper Surgical, Trumbull, CT, USA) depositing 0.2 or 0.5 ml of the sperm sample at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 p.m. After the procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day of the week, including weekends.
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine Insemination with 200 µl | Active comparator | The sperm sample will be concentrated by centrifugation to a volume of 200 µl Receives: Procedure: Intrauterine insemination |
| Intrauterine Insemination with 500 µl | Experimental | The sperm sample will be concentrated by centrifugation to a volume of 500 µl. Receives: Procedure: Intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: Ten months after insemination procedure
Secondary outcomes (1)
Miscarriage rate
Miscarriage was defined as a loss following a positive pregnancy test and/or detectable GS
Measured: Any pregnancy loss before week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Rodriguez-Purata, Fundacion Dexeus
- Investigators
- Jorge Rodriguez-Purata, MD, Principal investigator, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006523
- Sponsor's protocol ID
- SMD-DEX-2016-03
- Status last verified
- Jan 2017
- First submitted
- 27 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Veltman-Verhulst SM, Cohlen BJ, Hughes E, Heineman MJ. Intra-uterine insemination for unexplained subfertility. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD001838. doi: 10.1002/14651858.CD001838.pub4.
PubMed 22972053Cohlen BJ, Vandekerckhove P, te Velde ER, Habbema JD. Timed intercourse versus intra-uterine insemination with or without ovarian hyperstimulation for subfertility in men. Cochrane Database Syst Rev. 2000;(2):CD000360. doi: 10.1002/14651858.CD000360.
PubMed 10796711Goverde AJ, McDonnell J, Vermeiden JP, Schats R, Rutten FF, Schoemaker J. Intrauterine insemination or in-vitro fertilisation in idiopathic subfertility and male subfertility: a randomised trial and cost-effectiveness analysis. Lancet. 2000 Jan 1;355(9197):13-8. doi: 10.1016/S0140-6736(99)04002-7.
PubMed 10615885ESHRE Capri Workshop Group. Intrauterine insemination. Hum Reprod Update. 2009 May-Jun;15(3):265-77. doi: 10.1093/humupd/dmp003. Epub 2009 Feb 23.
PubMed 19240042Rodriguez-Purata J, Latre L, Ballester M, Gonzalez-Llagostera C, Rodriguez I, Gonzalez-Foruria I, Buxaderas R, Martinez F, Barri PN, Coroleu B. Clinical success of IUI cycles with donor sperm is not affected by total inseminated volume: a RCT. Hum Reprod Open. 2018 Feb 15;2018(2):hoy002. doi: 10.1093/hropen/hoy002. eCollection 2018.
PubMed 30895244
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inseminated Volume and Live Birth Rates After Intrauterine Insemination (IUI) With Donor Sperm (dIUI): A Prospective Randomized COntrolled Trial
- ClinicalTrials.gov ID
- NCT03006523
- Acronym / sponsor ID
- SMD-DEX-2016-03
- Conditions
- Infertility, Infertility, Male, Same-Sex Marriage, Parent, Single
- Keywords
- donor intrauterine insemination, insemination volume, Live Birth Rates, donor sperm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It is hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher clinical pregnancy rates will be achieved by promoting higher sperm densities in the fallopian tubes at the time of ovulation by decreasing the amount of sperm cells lost during preparation and handling.
Detailed description
A prospective RCT will be performed, including patients undergoing dIUI under ovulation induction. The trial is established to compare two inseminated volumes, 0.2 ml (control group) and 0.5 mL (study group), and will be conducted at the Reproductive Medicine Service of the Dexeus Women's Health Center. The Institutional Review Board has approved the research project and an informed consent will be obtained from all patients participating to the study.
All patients will undergo a full infertility investigation including hormonal evaluation between day 2 and day 5 of the cycle and confirmation of patency of the Fallopian tubes. Patients eligible for the study are between 18 and 40 years old, with regular menstrual cycles (21 - 35 days). Indications for the use of donor sperm are male factor infertility due to azoospermia or severe oligoasthenoteratozoospermia (requiring donor sperm), the presence of a heritable genetic disorder in the male partner, a single-parent request or same-sex couples' partners undergoing IUI. Exclusion criteria are the presence of tubal factor infertility, ≥grade III endometriosis, more than 3 previous dIUI cycles, or patients in whom ≥3 follicles >14mm are observed during the cycle. The randomization procedure will take place the day the donor IUI procedure. The randomization will be performed on the IUI cycle level. Randomization into one of the two groups will be performed using an open computer-generated list.
IUI will be performed with a Wallace® catheter depositing 0.2 or 0.5 ml of the sperm sample at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 pm. After the procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day of the week, including weekends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine Insemination with 200 µl | Active comparator | Procedure: Intrauterine inseminationThe sperm sample will be concentrated by centrifugation to a volume of 200 µl |
| Intrauterine Insemination with 500 µl | Experimental | Procedure: Intrauterine inseminationThe sperm sample will be concentrated by centrifugation to a volume of 500 µl. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients will undergo a full infertility investigation including hormonal evaluation between day 2 and day 5 of the cycle and confirmation of patency of the Fallopian tubes.
- Patients eligible for the study are between 18 and 40 years old and with regular menstrual cycles (21 - 35 days). Indications for the use of donor sperm are severe male factor infertility requiring donor sperm, the presence of a heritable genetic disorder in the male partner, a single-parent request or same-sex couples' partners undergoing IUI.
- Exclusion criteria are the presence of tubal factor infertility, grade III-IV endometriosis, more than 3 previous failed dIUI cycles, or patients in whom ≥3 follicles >14mm are observed during the IUI cycle. Patients will be included in the study only once. The randomization will be performed on the IUI cycle level. The group allocation will take place the day the dIUI and the biologist will randomized all included patients into one of the two groups using an open computer-generated list.
Key exclusion criteria (0 listed)
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 inseminationIUI will be performed with a Wallace® insemination 2 Catheter (Cooper Surgical, Trumbull, CT, USA) depositing 0.2 or 0.5 ml of the sperm sample at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 p.m. After the procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day of the week, including weekends. | Procedure or surgery | Intrauterine Insemination with 200 µl, Intrauterine Insemination with 500 µl |
Primary outcome
Live birth rate
Time frame: Ten months after insemination procedure
1 secondary outcome
Miscarriage rate
Time frame: Any pregnancy loss before week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Background: PubMed 22972053Veltman-Verhulst SM, Cohlen BJ, Hughes E, Heineman MJ. Intra-uterine insemination for unexplained subfertility. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD001838. doi: 10.1002/14651858.CD001838.pub4.
- Background: PubMed 10796711Cohlen BJ, Vandekerckhove P, te Velde ER, Habbema JD. Timed intercourse versus intra-uterine insemination with or without ovarian hyperstimulation for subfertility in men. Cochrane Database Syst Rev. 2000;(2):CD000360. doi: 10.1002/14651858.CD000360.
- Background: PubMed 10615885Goverde AJ, McDonnell J, Vermeiden JP, Schats R, Rutten FF, Schoemaker J. Intrauterine insemination or in-vitro fertilisation in idiopathic subfertility and male subfertility: a randomised trial and cost-effectiveness analysis. Lancet. 2000 Jan 1;355(9197):13-8. doi: 10.1016/S0140-6736(99)04002-7.
- Background: PubMed 19240042ESHRE Capri Workshop Group. Intrauterine insemination. Hum Reprod Update. 2009 May-Jun;15(3):265-77. doi: 10.1093/humupd/dmp003. Epub 2009 Feb 23.
- Derived from this study: PubMed 30895244Rodriguez-Purata J, Latre L, Ballester M, Gonzalez-Llagostera C, Rodriguez I, Gonzalez-Foruria I, Buxaderas R, Martinez F, Barri PN, Coroleu B. Clinical success of IUI cycles with donor sperm is not affected by total inseminated volume: a RCT. Hum Reprod Open. 2018 Feb 15;2018(2):hoy002. doi: 10.1093/hropen/hoy002. eCollection 2018.
- 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.
Jorge Rodriguez-Purata, MD principal investigator
Fundacion Dexeus
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine insemination in people with Infertility and Infertility, Male, run by Fundacion Dexeus.
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 0 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: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: Ten months after insemination procedure). 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 NCT03006523, which also lists 5 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 4 Jan 2017.