Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03823833
Other study ID # 2018_48
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 28, 2021
Est. completion date December 2022

Study information

Verified date December 2022
Source University Hospital, Lille
Contact Christine Decanter, MD
Phone 320445962
Email christine.decanter@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be necessary to identify the nature of the cyst and assess its benignity. In some case, cysts are recurrent and multiple surgeries are needed leading to a significant risk of ovarian damage by follicular depletion. Oocyte cryopreservation is no longer considered as an experimental technique of Fertility Preservation since 2013 as it has been recognized to be efficient and safe. According to reproductive medicine scientific committees and the French ethic law, fertility preservation has to be proposed in every situation of infertility risk. To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in this specific subgroup of patients. The purpose of the study is to prospectively evaluate the oocyte number and quality after controlled ovarian hyperstimulation in patients with recurrent ovarian cysts.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - women with benign ovarian tumor with high risk of recurrence, i-e, endometrioma, dermoid cysts or mucinous cysts. - women with previous surgery and/or high risk of ovarian damage: bilateral cysts, cyst diameter higher than 5 cms - Having a social insurance - Able to give an informed consent Exclusion Criteria: - Borderline tumors - Undetectable AMH levels - Personal history of thrombo-embolic events - pregnancy

Study Design


Locations

Country Name City State
France Hop Jeanne de Flandre Chu Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of mature oocytes eligible for cryopreservation After 15 days of controlled ovarian hyperstimulation (COH)
Secondary Percentage of immature or morphologically abnormal oocytes Real-time, the day of egg retrieval
Secondary Number of mature follicles (=15 mm) and intermediary (10-14 mm) during ovarian stimulation The day of HCG triggering at the end of ovarian stimulation
Secondary Questionnaire on tolerance and complications A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure. One week after the egg retrieval
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4