- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132818
Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple (SEXODON)
July 15, 2020 updated by: Centre Hospitalier Universitaire, Amiens
Sexual disorders associated with medical aid for procreation have already been demonstrated in several studies.
However, few of them are interested in the problem of patients in charge of donating gametes, and if studied, it is often restricted to donating sperm to a small number of patients.
For this reason, it would be interesting to study the impact of the intake and in charge and the treatments of the Medical Aid to the Procreation on this population of patients (including the patients treated in donation of sperm but also Those supported in oocyte donation)
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
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
-
-
Picardie
-
Amiens, Picardie, France, 80054
- CHU Amiens Picardie
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing AMP with donation of gametes whose objective is to detect and evaluate the prevalence of sexual disorders
Description
Inclusion Criteria:
Couple, male and female, meeting the legal criteria for access to medically assisted procreation: a couple, a woman under the age of 43, who can testify to a life together. Then breakdown into 3 inclusion groups:
- Group 1: Patients undergoing AMP with oocyte donation
- Group 2: couples supported in AMP with sperm donation
- Group 3: torque supported in intra torque AMP.
Exclusion Criteria:
- Patients who do not meet the legal criteria for access to the MPA.
- Patients in charge of Medical Assistance for Procreation "Viral Risk"
- Patients undergoing medical aid for procreation for pre-existing sexual dysfunction.
- Patients awaiting embryo reception.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients undergoing AMP with oocyte donation
|
To evaluate the prevalence of sexual disorders in patients receiving AMP
|
Couples supported in AMP with sperm donation
|
To evaluate the prevalence of sexual disorders in patients receiving AMP
|
Couples supported in AMP intra torque
|
To evaluate the prevalence of sexual disorders in patients receiving AMP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of anonymous sexual well-being questionnaires: one reserved for men, another reserved for women
Time Frame: 1 year
|
Analysis of anonymous sexual well-being questionnaires: one reserved for men, another reserved for women
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 20, 2017
Primary Completion (Actual)
February 20, 2019
Study Completion (Actual)
February 20, 2019
Study Registration Dates
First Submitted
April 14, 2017
First Submitted That Met QC Criteria
April 27, 2017
First Posted (Actual)
April 28, 2017
Study Record Updates
Last Update Posted (Actual)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 15, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RNI2016-25 Dr Scheffler
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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