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Migraine and Infertility (FERTIMIG)

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ClinicalTrials.gov Identifier: NCT03831659
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to determine the prevalence of migraine in infertile women and during in Vitro Fertilization protocol. Migraine is two to three times as common in women as in men. Migraine has considerable impact on quality of life. In Vitro Fertilization has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely linked to migraine and its fluctuations have been considered to trigger migrainous headaches.

Condition or disease Intervention/treatment
Migraine Other: self-questionnaires

Detailed Description:

In Vitro Fertilization has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely linked to migraine and its fluctuations have been considered to trigger migrainous headaches.

Both migraine and infertility are associated with impaired quality of life.

Objectives: to assess the prevalence of migraine in infertile women and during in Vitro Fertilization protocol in order to improve the management of these patients.

Protocol:

Women coming to consult at the Port Royal infertility center and meeting the inclusion (infertile women without long-term analgesic treatment) criteria will be offered the study. The information note and no objection form will be given by the gynecologist receiving them for consultation. After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches. The patient fills it immediately and gives it to the investigator. As part of the usual management, and regardless of their answers to the questionnaire, some of the patients will be reviewed in consultation for the programming of an IVF. During this "incoming" consultation with one of the midwives of the unit, a schedule of migraine headaches will be given to the patients. They will keep it, will complete it in case of migraine, and will give it to the gynecologist during the embryo transfer or the doctor receiving the couple in consultation on day 7 in case of absence of embryo transfer.


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Migraine in Infertile Women and Evolution During in Vitro Fertilization (IVF)
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility Migraine


Intervention Details:
  • Other: self-questionnaires
    After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches


Primary Outcome Measures :
  1. migraine [ Time Frame: At inclusion ]
    Prevalence of migrainous in infertile women


Secondary Outcome Measures :
  1. migraine [ Time Frame: At 2 months ]
    Prevalence of migrainous in infertile women



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Unit of assisted reproductive medicine in a University hospital
Criteria

Inclusion Criteria:

  • infertile women supported in reproductive medical assistance at the Port Royal infertility center
  • aged between 18 and 40 years old

Exclusion Criteria:

  • long-term analgesic treatment
  • women under guardianship or curatorship

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): NCT03831659


Locations
France
Hospital Port-Royal Recruiting
Paris, France, 75014
Contact: Justine HUGON-RODIN, MD PHD    33 1 58413550    justine.hugon-rodin@aphp.fr   
Contact: Caroline Tourte    33 1 58 41 11 90    caroline.tourte@aphp.fr   
Principal Investigator: Justine HUGON-RODIN, MD PHD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03831659     History of Changes
Other Study ID Numbers: APHP180064
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
migraine
in vitro fertilization
infertility

Additional relevant MeSH terms:
Migraine Disorders
Infertility
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genital Diseases, Male
Genital Diseases, Female