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

Not Applicable

Terminated

• Conditions: Infertilities
• Interventions: Procedure: Intra Uterine Insemination (IUI); Procedure: In Vitro Fecundation (IVF)

• Registration Number: NCT02001870
• Lead Sponsor: University Hospital, Toulouse

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 Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-28
• Study First Posted: 2013-12-05
• Study Start: 2014-05
• Status Verified: 2019-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra Uterine Insemination (IUI)	Intra Uterine Insemination (IUI)	Couples will be treated by Intra Uterine Insemination (IUI)
In Vitro Fecundation (IVF)	In Vitro Fecundation (IVF)	Couples will be treated by In Vitro Fecundation (IVF)

Primary Outcome Measures

Name	Time	Method
Delivery rate.	After one year of treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (12)

University Hospital; 🇫🇷 Toulouse, Midi-Pyrénnées, France

CHU Bordeaux Hôpital Pellegrin; 🇫🇷 Bordeaux, France

CHRU Brest Hôpital Morvan, service d'AMP; 🇫🇷 Brest, France

CHU Dijon Laboratoire de biologie de la reproduction; 🇫🇷 Dijon, France

Centre Hospitalier Intercommunal de Créteil, Service d'AMP; 🇫🇷 Créteil, 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