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

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.

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

Conditions
-----------------
Infertilities

Intervention / Treatment
-----------------
* Procedure: In Vitro Fecundation (IVF)
* Procedure: Intra Uterine Insemination (IUI)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 37 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In Vitro Fecundation (IVF)<br>Couples will be treated by In Vitro Fecundation (IVF) | Procedure: In Vitro Fecundation (IVF)<br>* In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center.<br>|
| Active Comparator: Intra Uterine Insemination (IUI)<br>Couples will be treated by Intra Uterine Insemination (IUI) | Procedure: Intra Uterine Insemination (IUI)<br>* Intra-uterine insemination will be performed according to the usual procedure of each ART center<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery rate. |  | After one year of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple pregnancy rate |  | After one year of treatment. | 
| Cost of treatment |  | After one year of treatment. | 
| Adverse effects (hyperstimulation, infections…) |  | After one year of treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, female age, intra-uterine insemination, in vitro fecundation, assisted reproductive technology center