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

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ClinicalTrials.gov Identifier: NCT03362489
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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

Condition or disease Intervention/treatment Phase
Infertility Procedure: IVF / IVF-ICSI Procedure: IUI Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
IVF / IVF-ICSI
In Vitro Fertilization / In Vitro Fertilization - Intracytoplasmic Sperm Injection (ICSI)
Procedure: IVF / IVF-ICSI
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.

IUI
Intrauterine insemination
Procedure: IUI
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.




Primary Outcome Measures :
  1. The main criterion is the live birth rate [ Time Frame: 12 months ]
    Defined as the birth of a living infant after 22 weeks gestational age (GA), or weighing ≥ 500 g.


Secondary Outcome Measures :
  1. Biochemical pregnancy rate [ Time Frame: 5 Weeks ]
    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.

  2. Clinical pregnancy rate [ Time Frame: 6-7 Weeks ]
    Defined as fetal cardiac activity at 6-7 weeks GA

  3. Spontaneous pregnancy loss (PL) rate [ Time Frame: 12 Weeks ]
    Including early and late pregnancy losses

  4. Multiple pregnancy rate [ Time Frame: 7-8 Weeks ]
    Defined as more than two embryos visualized on ultrasound at 7 weeks GA.

  5. Term at delivery [ Time Frame: 12 Months ]
    Term at delivery in Gestational age (GA)

  6. Neonatal complications [ Time Frame: 12 Months ]
    Neonatal complications

  7. Neonatal survival [ Time Frame: 12 Months ]
    Neonatal survival

  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) [ Time Frame: 12 Months ]
    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)

  9. All outcome measures will be further analyzed in the subgroup of women considered poor responders according to the Bologna criteria [ Time Frame: 12 Months ]
    Assess the clinical efficiency of conversion to IUI, compared to IVF, in women considered "poor ovarian responders" according to the Bologna criteria

  10. The rate of IVF cycles with empty follicle syndrome and no embryo transfers. [ Time Frame: 1 Week ]
    Analyze the rate of IVF cycles with empty follicle syndrome and no embryo transfers

  11. Cumulative clinical pregnancy and live birth rates in the IVF group, thus taking into account fresh and frozen embryos transferred in subsequent cycles [ Time Frame: 12 Months ]
    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

  12. Cost-efficiency analysis at 12 months [ Time Frame: 12 Months ]
    Compare the cost-efficiency of both strategies at 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
    • Natural and modified natural cycle protocols
  • Women under legal guardianship
  • Women with no health or social security coverage
  • Women participating in other interventional trials

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): NCT03362489


Contacts
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Contact: Pierre-Emmanuel BOUET, MD +33 (0)241354213 PierreEmmanuel.Bouet@chu-angers.fr

Locations
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France
UH Pointe-à-Pitre Not yet recruiting
Pointe-à-Pitre, Guadeloupe, France, 97110
Contact: Catherine Morinière, MD         
UH Angers Recruiting
Angers, France, 49000
Contact: Pierre-Emmanuel Bouet, MD    +33 (0)241354213    PierreEmmanuel.Bouet@chu-angers.fr   
Polyclinique Jean Villar Recruiting
Bruges, France, 33520
Contact: Xenia Lechat, MD         
UH Caen Recruiting
Caen, France, 14000
Contact: Claire De Vienne, MD         
Clinique Léonard de Vinci Recruiting
Chambray-lès-Tours, France, 37170
Contact: Claudine Vasseur, MD         
Antoine Béclère Hospital AP-HP Recruiting
Clamart, France, 92140
Contact: Michaël Grynberg, MD PhD         
IHC Créteil Recruiting
Créteil, France, 94000
Contact: Nathalie Massin, MD         
UH Grenoble Recruiting
Grenoble, France, 38000
Contact: Aurore Gueniffey, MD         
Lorient Hospital Recruiting
Lorient, France, 561000
Contact: Sophie Fressard, MD         
UH La conception AP-HM Not yet recruiting
Marseille, France, 13005
Contact: Blandine Courbière, MD PhD         
Clinique Jules Verne Recruiting
Nantes, France, 44000
Contact: Marie-Laure Langlois, MD         
UH Nantes Recruiting
Nantes, France, 44000
Contact: Florence Leperlier, MD         
Clinique Pierre Cherest Recruiting
Neuilly-sur-Seine, France, 92200
Contact: Frédéric Lamazou, MD         
Clinique Mutualiste de la Sagesse Recruiting
Rennes, France, 35000
Contact: Anne Guivarc'h-Levêque, MD         
UH Rennes Recruiting
Rennes, France, 35000
Contact: Mathilde Domin, MD         
Polyclinique de L'Atlantique Recruiting
Saint-Herblain, France, 44800
Contact: Anne-Cécile Vasseur, MD         
UH Strasbourg Recruiting
Strasbourg, France, 67000
Contact: olivier Pirrello, MD         
UHR Tours Recruiting
Tours, France, 37000
Contact: Marion Cornuau, MD         
Sponsors and Collaborators
University Hospital, Angers

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03362489     History of Changes
Other Study ID Numbers: 2017-A00862-51
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Angers:
In Vitro Fertilization
Intra-Uterine Insemination
Poor responders

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