Double vs Single Intrauterine Insemination in Male Factor Infertility

November 28, 2023 updated by: Merve Dizdar, Umraniye Education and Research Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Umraniye Training and Research Hospital
        • Contact:
          • Merve Dizdar

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Procedure: intrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter
Experimental: 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.
Procedure: intrauterine insemination
Giving washed sperm concentrate into uterine cavity via a soft catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinical pregnancy
Time Frame: Within 4-6 weeks after insemination
Pregnancy with fetal cardiac activity diagnosed by transvaginal ultrasonography
Within 4-6 weeks after insemination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of biochemical, ectopic pregnancies and rate of miscarriages
Time Frame: Within 3 months after insemination
Pregnancy outcomes including biochemical, ectopic pregnancies and miscarriages diagnosed by transvaginal ultrasonography
Within 3 months after insemination

Collaborators and Investigators

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

Sponsor

Umraniye Education and Research Hospital

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 (Actual)

June 5, 2023

Primary Completion (Estimated)

November 22, 2024

Study Completion (Estimated)

December 22, 2024

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.10.1.TKH.4.34.H.GP.0.01/384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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