Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors

NCT03823833 | Completed

• 1 other identifier: 2018_48
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Dermoid Cyst; Mucinous Cyst

Keywords

Oocyte freezing; fertility preservation; ovarian cysts; benign ovarian tumor; endometrioma

Outcome Measures

Primary Outcomes (1)

• Number of mature oocytes eligible for cryopreservation

  After 15 days of controlled ovarian hyperstimulation (COH)

Secondary Outcomes (3)

• Percentage of immature or morphologically abnormal oocytes

  Real-time, the day of egg retrieval

• 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

• Questionnaire on tolerance and complications

  One week after the egg retrieval

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: young women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Young women with benign ovarian tumors and high risk of further infertility due to surgery

You may qualify if:

• 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

You may not qualify if:

• Borderline tumors
• Undetectable AMH levels
• Personal history of thrombo-embolic events
• pregnancy

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Endometriosis; Dermoid Cyst; Mucocele; Ovarian Cysts

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Cysts; Neoplasms; Teratoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Christine Decanter, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 31, 2019
• Study Start: July 28, 2021
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)