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InfertilityConFIRMNCT03362489

Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation

A study testing IVF / IVF-ICSI and IUI in people with Infertility, run by University Hospital, Angers at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the efficiency of conversion to IUI and IVF in patients with a poor ovarian response to stimulation Read more about this study

Who is it for?
Ages 18 to 43 years, women only
Conditions the study is for
Infertility
What is being tested?
IVF / IVF-ICSI and IUI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
462 participants
Where
32 sitesin 2 countries
Study dates
10 Jan 2018to 14 Mar 2024
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 18 to 43 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients who accepted being included and signed the consent forms.
  • Age ≥18 years et <43 years.
  • IVF cycle with and without Intra Cytoplasmic Sperm Injection (ICSI):
  • "Conventional" Agonist (long and short) or antagonist protocol, using urinary or recombinant gonadotropins.
  • Having only 2, 3 or 4 mature follicles (≥14 mm) on ovulation trigger day.

Who cannot join

  • Confirmed bilateral tubal occlusion
  • Non-French speaking patients
  • Partners with severe oligoasthenoteratospermia (OATS) (<5 millions motile spermatozoa in the ejaculate)
  • Suboptimal stimulation protocols:
  • Protocols ≤ 150 IU of daily gonadotropins
  • Mild stimulation protocols
Show all 10Show fewer
  • Natural and modified natural cycle protocols
  • Women under legal guardianship
  • Women with no health or social security coverage
  • Women participating in other interventional trials

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

France31 sites

  • Victor Pauchet Clinic

    Amiens

  • UH Angers

    Angers, 49000

  • UH Besançon

    Besançon

  • Jean Verdier Hospital, APHP

    Bondy

  • Polyclinique Jean Villar

    Bruges, 33520

  • UH Caen

    Caen, 14000

  • Clinique Léonard de Vinci

    Chambray-lès-Tours, 37170

  • Cholet Hospital

    Cholet

  • Antoine Béclère Hospital AP-HP

    Clamart, 92140

  • Sud Francilien Hospital

    Corbeil-Essonnes

  • IHC Créteil

    Créteil, 94000

  • UH Grenoble

    Grenoble, 38000

  • Tertre Rouge Clinic

    Le Mans

  • UH Lille

    Lille

  • Lorient Hospital

    Lorient, 561000

  • UH La conception AP-HM

    Marseille, 13005

  • Clinique Jules Verne

    Nantes, 44000

  • UH Nantes

    Nantes, 44000

  • Clinique Pierre Cherest

    Neuilly-sur-Seine, 92200

  • UH Nîmes

    Nîmes

  • Hospital of Orléans

    Orléans

  • Cochin Hospital, APHP

    Paris

  • Poissy Saint Germain en Laye Hospital

    Poissy

  • UH Potiers

    Potiers

  • Clinique Mutualiste de la Sagesse

    Rennes, 35000

  • UH Rennes

    Rennes, 35000

  • UH Rouen

    Rouen

  • Polyclinique de L'Atlantique

    Saint-Herblain, 44800

  • UH Strasbourg

    Strasbourg, 67000

  • UH Toulouse

    Toulouse

  • UHR Tours

    Tours, 37000

Other trials in France

Guadeloupe1 site

  • UH Pointe-à-Pitre

    Pointe-à-Pitre, Guadeloupe/France, 97110

Other trials in Guadeloupe

About this study

The purpose of this study is to compare the efficiency of conversion to IUI and IVF in patients with a poor ovarian response to stimulation

Read the detailed description

In 5 to 10% of in vitro fertilization (IVF) cycles, a poor response to ovarian stimulation (defined as less than 4 mature follicles) is noted, even though high doses of exogenous gonadotropins are used. To date, there is no consensus on the ideal management strategy in poor responders. There are three therapeutic options available nowadays:

  1. Oocyte retrieval is performed and the IVF cycle continued, despite the low number of mature follicles.
  2. Conversion of the IVF cycle to an intrauterine insemination (IUI), on the condition of having at least one patent fallopian tube and good semen parameters.
  3. Cancelation of the IVF cycle. In everyday practice, it is difficult for the physician to cancel the IVF cycle in the presence of 2, 3 or 4 mature follicles, especially following a lengthy stimulation.

If live birth rates were comparable between IUI and IVF, conversion to IUI would be the better option for poor responders, since it would avoid an invasive procedure (oocyte retrieval) and the associated risk of complications, and is associated with at a lower cost.

To our knowledge, no prospective randomized controlled trial comparing IVF to conversion to IUI in poor responders has been published to date. The studies published so far have been retrospective and observational, and had several methodological flaws.

Therefore, we aimed to analyze whether conversion of IVF cycles to IUI in poor responders would result in the same live birth rates as oocyte retrievals followed by embryo transfers.

Conditions
Infertility
Being tested
IVF / IVF-ICSI, IUI
Keywords
In Vitro Fertilization, Intra-Uterine Insemination, Poor responders
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVF / IVF-ICSIProcedure or surgery

    In the "IVF" arm, oocyte retrieval is performed 36 hours after the HCG injection, in the operating room, under transvaginal ultrasound guidance, under local or general anesthesia. The procedure lasts about 20 minutes and the patients are discharged on the same day. The oocytes retrieved from the follicles are transported immediately to the lab for fertilization with the partner's sperm. Fertilization is done either via conventional IVF, or via ICSI, depending on the indication. Embryos are later transferred into the uterus on day 3 or day 5, under ultrasound guidance, in the outpatient department.

  • IUIProcedure or surgery

    In the "conversion to IUI" arm, IUI is performed 24 to 36 hours after ovulation trigger. The partner provides the sperm on site on the morning of the insemination, which is performed in the outpatient department.

Study groups in NCT03362489
Study groupRoleWhat they receive
IVF / IVF-ICSIOtherIn Vitro Fertilization / In Vitro Fertilization - Intracytoplasmic Sperm Injection (ICSI)
Receives: Procedure: IVF / IVF-ICSI
IUIOtherIntrauterine insemination
Receives: Procedure: IUI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The main criterion is the live birth rate

    Defined as the birth of a living infant after 22 weeks gestational age (GA), or weighing ≥ 500 g.

    Measured: 12 months

Secondary outcomes (12)

  1. Biochemical pregnancy rate

    Defined as serum HCG levels >10 IU/L, 14 days after the IUI or the embryo transfer, followed by a rapid decrease until being undetectable.

    Measured: 5 Weeks

  2. Clinical pregnancy rate

    Defined as fetal cardiac activity at 6-7 weeks GA

    Measured: 6-7 Weeks

  3. Spontaneous pregnancy loss (PL) rate

    Including early and late pregnancy losses

    Measured: 12 Weeks

  4. Multiple pregnancy rate

    Defined as more than two embryos visualized on ultrasound at 7 weeks GA.

    Measured: 7-8 Weeks

  5. Term at delivery

    Term at delivery in Gestational age (GA)

    Measured: 12 Months

  6. Neonatal complications

    Neonatal complications

    Measured: 12 Months

  7. Neonatal survival

    Neonatal survival

    Measured: 12 Months

  8. All outcome measure will be further analyzed according to the number of follicles on trigger day (2, 3 or 4) and patients' age (<40 years vs. ≥40 years)

    Assess the impact of conversion to IUI, compared to IVF, on overall outcomes in in women with a poor ovarian response to stimulation, according to the number of follicles on trigger day (2, 3 or 4) and patients' age (<40 years vs. ≥40 years)

    Measured: 12 Months

  9. All outcome measures will be further analyzed in the subgroup of women considered poor responders according to the Bologna criteria

    Assess the clinical efficiency of conversion to IUI, compared to IVF, in women considered "poor ovarian responders" according to the Bologna criteria

    Measured: 12 Months

  10. The rate of IVF cycles with empty follicle syndrome and no embryo transfers.

    Analyze the rate of IVF cycles with empty follicle syndrome and no embryo transfers

    Measured: 1 Week

  11. Cumulative clinical pregnancy and live birth rates in the IVF group, thus taking into account fresh and frozen embryos transferred in subsequent cycles

    Assess the impact of conversion to IUI, compared to IVF, on the cumulative clinical pregnancy and live birth rates - taking into account frozen embryo transfers in IVF - in women with a poor ovarian response to stimulation

    Measured: 12 Months

  12. Cost-efficiency analysis at 12 months

    Compare the cost-efficiency of both strategies at 12 months

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2017
  2. Study start10 Jan 2018
  3. Primary completion25 Nov 2022
  4. Study completion14 Mar 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03362489
Sponsor's protocol ID
2017-A00862-51
Acronym
ConFIRM
Status last verified
Jun 2024
First submitted
24 Nov 2017
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Delbos L, Parot-Schinkel E, El Hachem H, Legendre G, Descamps P, Boucret L, Ferre-L'Hotellier V, Jeanneteau P, Dreux C, Moriniere C, May-Panloup P, Bouet PE. ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial. Trials. 2018 Oct 17;19(1):565. doi: 10.1186/s13063-018-2936-5.

    PubMed 30333054

Questions about this trial

What is this clinical trial studying?

A study testing IVF / IVF-ICSI and IUI in people with Infertility, run by University Hospital, Angers at 32 sites in 2 countries.

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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in France, Guadeloupe. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The main criterion is the live birth rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03362489, which also lists 1 linked publication.

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 18 Jun 2024.

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