Migraine and Infertility (FERTIMIG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03831659|
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment|
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.
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|
|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|
- 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
- migraine [ Time Frame: At inclusion ]Prevalence of migrainous in infertile women
- migraine [ Time Frame: At 2 months ]Prevalence of migrainous in infertile women
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
|Paris, France, 75014|
|Contact: Justine HUGON-RODIN, MD PHD 33 1 58413550 email@example.com|
|Contact: Caroline Tourte 33 1 58 41 11 90 firstname.lastname@example.org|
|Principal Investigator: Justine HUGON-RODIN, MD PHD|