0.2 ml vs. 0.5 Inseminated Volume in Donor Intrauterine Insemination Cycles: A Prospective RCT

January 2, 2017 updated by: Jorge Rodriguez-Purata, Institut Universitari Dexeus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
293

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Intrauterine Insemination with 200 µl
The sperm sample will be concentrated by centrifugation to a volume of 200 µl
Procedure: Intrauterine insemination
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.
EXPERIMENTAL: Intrauterine Insemination with 500 µl
The sperm sample will be concentrated by centrifugation to a volume of 500 µl.
Procedure: Intrauterine insemination
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Live birth rate
Time Frame: Ten months after insemination procedure
Ten months after insemination procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Miscarriage rate
Time Frame: Any pregnancy loss before week 20
Miscarriage was defined as a loss following a positive pregnancy test and/or detectable GS
Any pregnancy loss before week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMD-DEX-2016-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Intrauterine insemination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings