Skip to main content
Clinical Trials/NCT02001870
NCT02001870TerminatedNot Applicable

Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years

University Hospital, Toulouse13 sites in 1 country88 target enrollmentStarted: May 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
88
Locations
13
Primary Endpoint
Delivery rate.

Study Overview

Brief Summary

As age increases the chances for a woman to become pregnant decrease as well spontaneously as through assisted reproductive technologies (ART). For the treatment of unexplained infertilities two techniques can be used: intra-uterine insemination (IUI) and in vitro fertilization (IVF). The aim of the present study is to compare the efficiency in term of delivery rate of IUI and IVF in couples in whom the female age is over 37 years.

Detailed Description

IUI can be used to treat infertility when tubes are normal, with no severe endometriosis and enough motile spermatozoa can be inseminated. In these cases IUI are usually performed (4 to 6 attempts) and IVF only in case of IUI failure. Indeed if the pregnancy rate per attempt is higher with IVF, IUI can be performed more frequently (6 times a year vs. 2 for IVF) so that the pregnancy rates after one year of treatment are close. When female age is over 37 years, some ART centers prefer to perform directly IVF, since chances of pregnancy decreases with time. However there is no argument in the literature in favor as well as in disfavor for such an attitude. Indeed the delivery rates after one year treatment with IUI or IVF are not known in this population. Therefore we propose a multicentric randomized controlled trial comparing IUI and IVF in women over 37 with unexplained infertility. Couples will be randomly allocated to IUI or IVF during one year. In case of absence of pregnancy after 4 IUI, couples will be treated by IVF. ART attempts will be performed according to usual procedures of each center. The follow-up will be ended either at the end of the first year of treatment if no pregnancy is obtained or at the time of delivery if a pregnancy is obtained. All data of attempts (demographics data, type and doses of treatment, adverse effects, outcome, number and health state of newborns....) will be recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
37 Years to 42 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Female age between 37 and 42 years at the time of inclusion
  • Infertility duration ≥ 12 months
  • Normal tubes
  • No severe endometriosis
  • At least 1.5 106 motile spermatozoa to be inseminated
  • No previous ART attempt

Exclusion Criteria

  • Tubal abnormalities
  • Severe endometriosis
  • Less than 1.5 106 motile spermatozoa to be inseminated
  • Use of frozen sperm
  • Presence of anti-spermatozoa antibodies

Outcomes

Primary Outcomes

Delivery rate.

Time Frame: After one year of treatment.

Secondary Outcomes

  • Adverse effects (hyperstimulation, infections…)(After one year of treatment.)
  • Multiple pregnancy rate(After one year of treatment.)
  • Cost of treatment(After one year of treatment.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

Loading locations...

Similar Trials

Comparison of the Efficiency of... | Clinical Trial