0.2 ml vs. 0.5 Inseminated Volume in Donor Intrauterine Insemination Cycles: A Prospective RCT
Condition: Infertility; Infertility, Male; Same-Sex Marriage; Parent, Single
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

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.
    

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.
    

Intervention name(s): Intrauterine insemination
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: donor intrauterine insemination; insemination volume; Live Birth Rates; donor sperm