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OpenTrials
Completed

NCT Number: NCT03823833

Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors

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.

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Key information

Conditions

Endometriosis Adnexal Diseases Cysts Dermoid Cyst Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Mucinous Cyst Mucocele Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Ovarian Cysts Ovarian Diseases Teratoma Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of mature oocytes eligible for cryopreservation

    Time frame: After 15 days of controlled ovarian hyperstimulation (COH)

Secondary outcomes

  1. Percentage of immature or morphologically abnormal oocytes

    Time frame: Real-time, the day of egg retrieval

  2. Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation

    Time frame: The day of HCG triggering at the end of ovarian stimulation

  3. Questionnaire on tolerance and complications

    Time frame: One week after the egg retrieval

    A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence

Acronym: OFBOT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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