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

Infertilities Clinical Trial

— AMPAGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02001870
• Other study ID #: RC31/12/0553
• Secondary ID: National PHRC 20
• Status: Terminated
• Phase: N/A
• Start date: May 2014
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 37 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertilities
• Infertility

Intervention

Procedure:
• In Vitro Fecundation (IVF)
In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center.
• Intra Uterine Insemination (IUI)
Intra-uterine insemination will be performed according to the usual procedure of each ART center

Locations

Country	Name	City	State
France	CHU Bordeaux Hôpital Pellegrin	Bordeaux
France	CHRU Brest Hôpital Morvan, service d'AMP	Brest
France	Centre Hospitalier Intercommunal de Créteil, Service d'AMP	Créteil
France	CHU Dijon Laboratoire de biologie de la reproduction	Dijon
France	Institut de Médecine de la Reproduction	Marseille
France	CHU Montpellier, Médecine de la Reproduction	Montpellier
France	CHU Nantes centre d'AMP	Nantes
France	CHU Nice centre d'AMP	Nice
France	CHI Poissy St-Germain en Laye, centre d'AMP	Poissy
France	Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction	Saint-Cloud
France	CHU de Strasbourg, Centre d'AMP	Strasbourg
France	University Hospital	Toulouse	Midi-Pyrénnées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery rate.		After one year of treatment.
Secondary	Multiple pregnancy rate		After one year of treatment.
Secondary	Cost of treatment		After one year of treatment.
Secondary	Adverse effects (hyperstimulation, infections…)		After one year of treatment.