NCT03831659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

January 17, 2019

Last Update Submit

September 8, 2025

Conditions

Migraine

Keywords

migrainein vitro fertilizationinfertility

Outcome Measures

Primary Outcomes (1)

  • migraine

    Prevalence of migrainous in infertile women

    At inclusion

Secondary Outcomes (1)

  • migraine

    At 2 months

Interventions

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

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Unit of assisted reproductive medicine in a University hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Port-Royal

Paris, 75014, France

Location

MeSH Terms

Conditions

Migraine DisordersInfertility

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

February 6, 2019

Study Start

March 13, 2019

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)