NCT03006523

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

December 27, 2016

Last Update Submit

January 2, 2017

Conditions

InfertilityInfertility, MaleSame-Sex MarriageParent, Single

Keywords

donor intrauterine inseminationinsemination volumeLive Birth Ratesdonor sperm

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    Ten months after insemination procedure

Secondary Outcomes (1)

  • Miscarriage rate

    Any pregnancy loss before week 20

Study Arms (2)

Intrauterine Insemination with 200 µl

ACTIVE COMPARATOR

The sperm sample will be concentrated by centrifugation to a volume of 200 µl

Procedure: Intrauterine insemination

Intrauterine Insemination with 500 µl

EXPERIMENTAL

The sperm sample will be concentrated by centrifugation to a volume of 500 µl.

Procedure: Intrauterine insemination

Interventions

Intrauterine inseminationPROCEDURE

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.

Intrauterine Insemination with 200 µlIntrauterine Insemination with 500 µl

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 22972053BACKGROUND

  • Cohlen 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.

    PMID: 10796711BACKGROUND

  • Goverde 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.

    PMID: 10615885BACKGROUND

  • ESHRE Capri Workshop Group. Intrauterine insemination. Hum Reprod Update. 2009 May-Jun;15(3):265-77. doi: 10.1093/humupd/dmp003. Epub 2009 Feb 23.

    PMID: 19240042BACKGROUND

  • Rodriguez-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.

    PMID: 30895244DERIVED

MeSH Terms

Conditions

InfertilityInfertility, Male

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Study Officials

  • Jorge Rodriguez-Purata, MD

    Fundacion Dexeus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician of IVF Center

Study Record Dates

First Submitted

December 27, 2016

First Posted

December 30, 2016

Study Start

March 1, 2013

Primary Completion

April 1, 2016

Study Completion

November 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share