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

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.

Study Overview

• Status: Terminated
• Conditions: Infertilities
• Intervention / Treatment: Procedure: In Vitro Fecundation (IVF); Procedure: Intra Uterine Insemination (IUI)

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux Hôpital Pellegrin
  • Brest, France
    • CHRU Brest Hôpital Morvan, service d'AMP
  • Créteil, France
    • Centre Hospitalier Intercommunal de Créteil, Service d'AMP
  • Dijon, France
    • CHU Dijon Laboratoire de biologie de la reproduction
  • Marseille, France
    • Institut de Médecine de la Reproduction
  • Montpellier, France
    • CHU Montpellier, Médecine de la Reproduction
  • Nantes, France
    • CHU Nantes centre d'AMP
  • Nice, France
    • CHU Nice centre d'AMP
  • Poissy, France
    • CHI Poissy St-Germain en Laye, centre d'AMP
  • Saint-Cloud, France
    • Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction
  • Strasbourg, France
    • CHU de Strasbourg, Centre d'AMP
  • Midi-Pyrénnées
    • Toulouse, Midi-Pyrénnées, France, 31059
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Jean PARINAUD, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 28, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Infertility; intra-uterine insemination; female age; in vitro fecundation; assisted reproductive technology center
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RC31/12/0553; National PHRC 2012 (Other Grant/Funding Number: Ministère des affaires sociales et de la santé)