MigraineFERTIMIGNCT03831659
Migraine and Infertility
An observational study of Migraine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- self-questionnaires
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2019to 26 Mar 2020
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Unit of assisted reproductive medicine in a University hospital
Who may be able to join
- infertile women supported in reproductive medical assistance at the Port Royal infertility center
- aged between 18 and 40 years old
Who cannot join
- long-term analgesic treatment
- women under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Migraine in Infertile Women and Evolution During in Vitro Fertilization (IVF)
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- self-questionnaires
- Keywords
- migraine, in vitro fertilization, infertility
- Medical subject headings
- Migraine Disorders, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnairesOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
migraine
Prevalence of migrainous in infertile women
Measured: At inclusion
Secondary outcomes (1)
migraine
Prevalence of migrainous in infertile women
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start13 Mar 2019
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831659
- Sponsor's protocol ID
- APHP180064
- Acronym
- FERTIMIG
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Migraine in Infertile Women and Evolution During in Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT03831659
- Acronym / sponsor ID
- FERTIMIG / APHP180064
- Conditions
- Migraine
- Keywords
- migraine, in vitro fertilization, infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Unit of assisted reproductive medicine in a University hospital
Key inclusion criteria (2 listed)
- infertile women supported in reproductive medical assistance at the Port Royal infertility center
- aged between 18 and 40 years old
Key exclusion criteria (2 listed)
- long-term analgesic treatment
- women under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-questionnairesAfter 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 | Other | – |
Primary outcome
migraine
Time frame: At inclusion
Prevalence of migrainous in infertile women
1 secondary outcome
migraine
Time frame: At 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 2 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
migraine (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.