Clinical trial NCT02001870: Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years
Official title: Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertilities
Keywords: Infertility
female age
intra-uterine insemination
in vitro fecundation
assisted reproductive technology center
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 88
Sex: FEMALE
Minimum age (years): 37
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delivery rate.
timeFrame: After one year of treatment.
Secondary outcomes:
measure: Multiple pregnancy rate
timeFrame: After one year of treatment.
measure: Cost of treatment
timeFrame: After one year of treatment.
measure: Adverse effects (hyperstimulation, infections…)
timeFrame: After one year of treatment.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
state: Midi-Pyrénnées
city: Bordeaux
country: France
facility: CHU Bordeaux Hôpital Pellegrin
city: Brest
country: France
facility: CHRU Brest Hôpital Morvan, service d'AMP
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil, Service d'AMP
city: Dijon
country: France
facility: CHU Dijon Laboratoire de biologie de la reproduction
city: Marseille
country: France
facility: Institut de Médecine de la Reproduction
city: Montpellier
country: France
facility: CHU Montpellier, Médecine de la Reproduction
city: Nantes
country: France
facility: CHU Nantes centre d'AMP
city: Nice
country: France
facility: CHU Nice centre d'AMP
city: Poissy
country: France
facility: CHI Poissy St-Germain en Laye, centre d'AMP
city: Saint-Cloud
country: France
facility: Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction
city: Strasbourg
country: France
facility: CHU de Strasbourg, Centre d'AMP
Study officials:
affiliation: University Hospital of Toulouse
name: Jean PARINAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: