Clinical trial NCT03831659: Migraine and Infertility
Official title: Prevalence of Migraine in Infertile Women and Evolution During in Vitro Fertilization (IVF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: migraine
in vitro fertilization
infertility
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unit of assisted reproductive medicine in a University hospital

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.

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.

Eligibility 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

Primary outcomes:
measure: migraine
timeFrame: At inclusion
Secondary outcomes:
measure: migraine
timeFrame: At 2 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Port-Royal
Study officials:
References: