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

NCT02001870 | Terminated

• 2 other identifiers: RC31/12/0553National PHRC 2012
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 12

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.

Conditions

Infertilities

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Delivery rate.

  After one year of treatment.

Secondary Outcomes (3)

• 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.

Study Arms (2)

In Vitro Fecundation (IVF)

EXPERIMENTAL

Couples will be treated by In Vitro Fecundation (IVF)

Procedure: In Vitro Fecundation (IVF)

Intra Uterine Insemination (IUI)

ACTIVE COMPARATOR

Couples will be treated by Intra Uterine Insemination (IUI)

Procedure: Intra Uterine Insemination (IUI)

Interventions

In Vitro Fecundation (IVF) PROCEDURE

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

In Vitro Fecundation (IVF)

Intra Uterine Insemination (IUI) PROCEDURE

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

Intra Uterine Insemination (IUI)

Eligibility Criteria

• Age: 37 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertility duration ≥ 12 months
• Normal tubes
• No severe endometriosis
• At least 1.5 106 motile spermatozoa to be inseminated
• No previous ART attempt

You may not qualify if:

• Tubal abnormalities
• Severe endometriosis
• Less than 1.5 106 motile spermatozoa to be inseminated
• Use of frozen sperm
• Presence of anti-spermatozoa antibodies

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (12)

University Hospital

Toulouse, Midi-Pyrénnées, 31059, France

Location

CHU Bordeaux Hôpital Pellegrin

Bordeaux, France

Location

CHRU Brest Hôpital Morvan, service d'AMP

Brest, France

Location

Centre Hospitalier Intercommunal de Créteil, Service d'AMP

Créteil, France

Location

CHU Dijon Laboratoire de biologie de la reproduction

Dijon, France

Location

Institut de Médecine de la Reproduction

Marseille, France

Location

CHU Montpellier, Médecine de la Reproduction

Montpellier, France

Location

CHU Nantes centre d'AMP

Nantes, France

Location

CHU Nice centre d'AMP

Nice, France

Location

CHI Poissy St-Germain en Laye, centre d'AMP

Poissy, France

Location

Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction

Saint-Cloud, France

Location

CHU de Strasbourg, Centre d'AMP

Strasbourg, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jean PARINAUD, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 5, 2013
• Study Start: May 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

FR (12)