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

NCT03006523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2017-01-04

No results posted yet for this study

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 the amount of sperm cells lost during preparation and handling.

Conditions

  • Infertility
  • Infertility, Male
  • Same-Sex Marriage
  • Parent, Single

Interventions

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.

Sponsors & Collaborators

  • Fundacion Dexeus

    lead OTHER

Principal Investigators

  • Jorge Rodriguez-Purata, MD · Fundacion Dexeus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-04-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03006523 on ClinicalTrials.gov