Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
PRIMIV
1 other identifier
interventional
204
1 country
1
Brief Summary
Oocyte vitrification after in vitro maturation (IVM) is one of the main techniques for preserving female fertility before chemotherapy for breast cancer. In this technique, originally developed for patients with ovarian pathology, polycystic ovarian syndrome, induction of an LH peak has been shown to improve outcomes. Young women with breast cancer, who are candidates for urgent fertility preservation, do not have ovarian pathology. The objective of the present study is to assess whether the absence of therapeutic intervention prior to oocyte retrieval for IVM in these patients is at least as effective as the injection of hCG or GnRH agonist used in routine practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2014
CompletedFirst Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2019
CompletedMay 20, 2019
May 1, 2019
5 years
May 16, 2019
May 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
total number of mature oocytes cryopreserved
Total number of mature oocytes obtained and cryopreserved after IVM
4 days
Secondary Outcomes (2)
number of COCS recovered
36 hours
maturation rate
4 days
Study Arms (3)
Without injection group
EXPERIMENTALno injection used as priming
hCG group
ACTIVE COMPARATORhCG used as priming
GnRHa group
ACTIVE COMPARATORGnRH agonist used as priming
Interventions
a subcutaneous injection of hCG (Choriogonadotropin alpha, Ovitrelle®, Merck Serono, 250 µg) is performed 36 hours before oocytes retrieval
a subcutaneous injection of GnRH agonist (triptorelin, Decapeptyl, Ipsen, 0,2 mg) is performed 36 hours before oocytes retrieval
Eligibility Criteria
You may qualify if:
- age between 18 and 38 years;
- diagnosis of breast cancer (BC)
- indication for neoadjuvant chemotherapy;
- body mass index (BMI) ≤27kg/m2; regular ovulatory cycles;
- transvaginal ultrasound showing the presence of two ovaries with an antral follicle count (AFC) between 10 and 30 follicles;
- affiliation to the national social security system.
- Written informed consent was obtained from all participants
You may not qualify if:
- \- previous chemotherapy, ovarian surgery or endometrioma;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Jean Verdier
Bondy, 93140, France
Related Publications (1)
Sonigo C, Le Conte G, Boubaya M, Ohanyan H, Presse M, El Hachem H, Cedrin-Durnerin I, Benoit A, Sifer C, Sermondade N, Grynberg M. Priming Before In Vitro Maturation Cycles in Cancer Patients Undergoing Urgent Fertility Preservation: a Randomized Controlled Study. Reprod Sci. 2020 Dec;27(12):2247-2256. doi: 10.1007/s43032-020-00244-0. Epub 2020 Jul 2.
PMID: 32617881DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 17, 2019
Study Start
September 9, 2014
Primary Completion
September 9, 2019
Study Completion
October 9, 2019
Last Updated
May 20, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share