InfertilitiesAMPAGENCT02001870
Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years
A study testing In Vitro Fecundation (IVF) and Intra Uterine Insemination (IUI) in people with Infertilities, run by University Hospital, Toulouse at 12 sites in France.
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). Read more about this study
- Who is it for?
- Ages 37 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertilities
- What is being tested?
- In Vitro Fecundation (IVF) and Intra Uterine Insemination (IUI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 12 sitesFrance
- Study dates
- May 2014to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Tubal abnormalities
- Severe endometriosis
- Less than 1.5 106 motile spermatozoa to be inseminated
- Use of frozen sperm
- Presence of anti-spermatozoa antibodies
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU Bordeaux Hôpital Pellegrin
Bordeaux
CHRU Brest Hôpital Morvan, service d'AMP
Brest
Centre Hospitalier Intercommunal de Créteil, Service d'AMP
Créteil
CHU Dijon Laboratoire de biologie de la reproduction
Dijon
Institut de Médecine de la Reproduction
Marseille
CHU Montpellier, Médecine de la Reproduction
Montpellier
CHU Nantes centre d'AMP
Nantes
CHU Nice centre d'AMP
Nice
CHI Poissy St-Germain en Laye, centre d'AMP
Poissy
Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction
Saint-Cloud
CHU de Strasbourg, Centre d'AMP
Strasbourg
University Hospital
Toulouse, Midi-Pyrénnées, 31059
About this study
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.
Read the 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.
- Conditions
- Infertilities
- Being tested
- In Vitro Fecundation (IVF), Intra Uterine Insemination (IUI)
- Keywords
- Infertility, female age, intra-uterine insemination, in vitro fecundation, assisted reproductive technology center
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro Fecundation (IVF)Procedure or surgery
In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center.
Intra Uterine Insemination (IUI)Procedure or surgery
Intra-uterine insemination will be performed according to the usual procedure of each ART center
| Study group | Role | What they receive |
|---|---|---|
| In Vitro Fecundation (IVF) | Experimental | Couples will be treated by In Vitro Fecundation (IVF) Receives: Procedure: In Vitro Fecundation (IVF) |
| Intra Uterine Insemination (IUI) | Active comparator | Couples will be treated by Intra Uterine Insemination (IUI) Receives: Procedure: Intra Uterine Insemination (IUI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery rate.
Measured: After one year of treatment.
Secondary outcomes (3)
Multiple pregnancy rate
Measured: After one year of treatment.
Cost of treatment
Measured: After one year of treatment.
Adverse effects (hyperstimulation, infections…)
Measured: After one year of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionJul 2019
- Study completionJul 2019
Why it stopped: Recuitment target non obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilitiesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean PARINAUD, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001870
- Sponsor's protocol ID
- RC31/12/0553
- Other IDs
- National PHRC 2012
- Acronym
- AMPAGE
- Status last verified
- Jul 2019
- First submitted
- 22 Nov 2013
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years
- ClinicalTrials.gov ID
- NCT02001870
- Acronym / sponsor ID
- AMPAGE / RC31/12/0553
- Conditions
- Infertilities
- Keywords
- Infertility, female age, intra-uterine insemination, in vitro fecundation, assisted reproductive technology center
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recuitment target non obtained
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Vitro Fecundation (IVF) | Experimental | Procedure: In Vitro Fecundation (IVF)Couples will be treated by In Vitro Fecundation (IVF) |
| Intra Uterine Insemination (IUI) | Active comparator | Procedure: Intra Uterine Insemination (IUI)Couples will be treated by Intra Uterine Insemination (IUI) |
Who may qualify
- Ages
- 37 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Tubal abnormalities
- Severe endometriosis
- Less than 1.5 106 motile spermatozoa to be inseminated
- Use of frozen sperm
- Presence of anti-spermatozoa antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In Vitro Fecundation (IVF)In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center. | Procedure or surgery | In Vitro Fecundation (IVF) |
| Intra Uterine Insemination (IUI)Intra-uterine insemination will be performed according to the usual procedure of each ART center | Procedure or surgery | Intra Uterine Insemination (IUI) |
Primary outcome
Delivery rate.
Time frame: After one year of treatment.
3 secondary outcomes
Multiple pregnancy rate
Time frame: After one year of treatment.
Cost of treatment
Time frame: After one year of treatment.
Adverse effects (hyperstimulation, infections…)
Time frame: After one year of treatment.
Results and safety
The study was stopped early (reason given: Recuitment target non obtained). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Related trials for Infertilities
Not yet recruiting
Evaluation of the Effect of a Dietary Supplement Based on EGCG, Vitamin B12, Hyaluronic Acid, and Folic Acid on the Maintenance of Physiological Balance and the Natural Defenses of the Male Genital System in Subjects Exposed to HPV Infection.
HPV Infection, Infertilities
Not yet recruiting
Effect of a Dietary Supplement Containing EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid in Supporting Male Genital Balance in Subjects Exposed to HPV Risk
HPV - Anogenital Human Papilloma Virus Infection, Infertilities
RecruitingPhase 4
Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET)
Infertilities, Embryo Transfer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean PARINAUD, MD principal investigator
University Hospital of Toulouse
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Vitro Fecundation (IVF) and Intra Uterine Insemination (IUI) in people with Infertilities, run by University Hospital, Toulouse at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recuitment target non obtained). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery rate. (time frame: After one year of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.