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

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ClinicalTrials.gov Identifier: NCT02001870
Recruitment Status : Recruiting
First Posted : December 5, 2013
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infertilities Procedure: In Vitro Fecundation (IVF) Procedure: Intra Uterine Insemination (IUI) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years
Actual Study Start Date : May 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. Delivery rate. [ Time Frame: After one year of treatment. ]

Secondary Outcome Measures :
  1. Multiple pregnancy rate [ Time Frame: After one year of treatment. ]
  2. Cost of treatment [ Time Frame: After one year of treatment. ]
  3. Adverse effects (hyperstimulation, infections…) [ Time Frame: After one year of treatment. ]


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Ages Eligible for Study:   37 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001870


Contacts
Contact: Jean PARINAUD, MD 05 67 77 10 02 ext 33 parinaud.j@chu-toulouse.fr
Contact: Caroline PEYROT, CRA 05 61 77 84 86 ext 33 peyrot.c@chu-toulouse.fr

Locations
France
University Hospital Recruiting
Toulouse, Midi-Pyrénnées, France, 31059
Contact: Jean Parinaud, MD    05 67 77 10 02 ext 33    parinaud.j@chu-toulouse.fr   
Contact: Roger Léandri, MD    05 67 77 10 02 ext 33    leandri.r@chu-toulouse.fr   
Principal Investigator: Jean PARINAUD, MD         
Sub-Investigator: Roger LEANDRI, MD         
Sub-Investigator: Carole FAJAU-PREVOT, MD         
Sub-Investigator: Florence LESOURD, MD         
Sub-Investigator: Tiffany COCHET, MD         
CHU Bordeaux Hôpital Pellegrin Recruiting
Bordeaux, France
Contact: Clément Jimenez, MD         
Principal Investigator: Clément Jiménez, MD         
CHRU Brest Hôpital Morvan, service d'AMP Recruiting
Brest, France
Contact: Philippe Merviel       philippe.merviel@chu-brest.fr   
Principal Investigator: Philippe Merviel         
Centre Hospitalier Intercommunal de Créteil, Service d'AMP Recruiting
Créteil, France
Contact: Nathalie Massin       nathalie.massin@chicreteil.fr   
Principal Investigator: Nathalie Massin         
CHU Dijon Laboratoire de biologie de la reproduction Terminated
Dijon, France
Institut de Médecine de la Reproduction Recruiting
Marseille, France
Contact: Géraldine Porcu, MD         
Principal Investigator: Géraldine Porcu, MD         
CHU Montpellier, Médecine de la Reproduction Terminated
Montpellier, France
CHU Nantes centre d'AMP Recruiting
Nantes, France
Contact: Paul Barrière, MD         
Principal Investigator: Paul Barrière, MD         
CHU Nice centre d'AMP Terminated
Nice, France
CHI Poissy St-Germain en Laye, centre d'AMP Recruiting
Poissy, France
Contact: Robert Wainer, MD         
Principal Investigator: Robert Wainer, MD         
Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction Recruiting
Saint-Cloud, France
Contact: Joelle Belaisch-Allart       j.belaischallart@gmail.com   
Principal Investigator: Joelle Belaisch-Allart         
CHU de Strasbourg, Centre d'AMP Recruiting
Strasbourg, France
Contact: Catherine Rongieres       catherine.rongieres@chru-strasbourg.fr   
Principal Investigator: Catherine Rongieres         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jean PARINAUD, MD University Hospital of Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02001870     History of Changes
Other Study ID Numbers: RC31/12/0553
National PHRC 2012 ( Other Grant/Funding Number: Ministère des affaires sociales et de la santé )
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Keywords provided by University Hospital, Toulouse:
Infertility
female age
intra-uterine insemination
in vitro fecundation
assisted reproductive technology center

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female