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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02001870

Acronym

AMPAGE

Enrollment

Registered

2013-12-05

Start date

2014-05-31

Completion date

2019-07-31

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertilities

Keywords

Infertility, female age, intra-uterine insemination, in vitro fecundation, assisted reproductive technology center

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.

Interventions

PROCEDUREIn Vitro Fecundation (IVF)

In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center.

PROCEDUREIntra Uterine Insemination (IUI)

Intra-uterine insemination will be performed according to the usual procedure of each ART center

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

37 Years to 42 Years

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

Design outcomes

Primary

Measure	Time frame
Delivery rate.	After one year of treatment.

Secondary

Measure	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026