Migraine and Infertility (FERTIMIG)

September 22, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hospital Port-Royal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Unit of assisted reproductive medicine in a University hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
migraine
Time Frame: At inclusion
Prevalence of migrainous in infertile women
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
migraine
Time Frame: At 2 months
Prevalence of migrainous in infertile women
At 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2019

Primary Completion (ACTUAL)

March 26, 2020

Study Completion (ACTUAL)

March 26, 2020

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (ACTUAL)

February 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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