- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954197
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients (PRIMIV)
May 16, 2019 updated by: Michael Grynberg, Hôpital Jean Verdier
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients: a Randomized Controlled Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In vitro maturation (IVM) is an assisted reproductive technology which consists in the retrieval of immature cumulus-oocyte complexes (COCs) from small antral follicles, followed by their in vitro maturation in specific culture conditions.
Oocytes having reached metaphase II (MII) stage after 24 to 48 hours of IVM can then be fertilized.
This procedure was first developed for patients presenting polycystic ovarian syndrome (PCOS), in order to avoid ovarian hyperstimulation syndrome (OHSS), an iatrogenic consequence of exogenous gonadotropins administration.
However, the increasing use of GnRH antagonist protocols allowing ovulation trigger with GnRH agonist has dramatically reduced the indication of IVM in women at risk of OHSS.
Yet, evidence indicate that IVM may be considered for patients presenting FSH resistance or contraindications to controlled ovarian stimulation.
The recent development of female fertility preservation (FP) renewed interest to this technique.
Indeed, it can be performed without any prior ovarian stimulation and whatever the phase of the menstrual cycle.
Although it is still considered experimental, oocyte vitrification following IVM has been applied in different groups of patients, in particular those diagnosed with breast cancer, autoimmune or ovarian diseases.
In physiologic conditions, final follicular maturation is induced by a double FSH and LH release which occurs when the dominant follicle reaches approximately 17 to 20 mm in diameter.
This gonadotropin surge usually precedes the follicular rupture and mature oocyte release from 36 to 40 hours.
In case of an assisted reproductive treatment, two strategies can be used to reproduce this hormonal signal: (i) either an injection of hCG, which binds to the LH receptor on granulosa cells, (ii) or a GnRH agonist (GnRHa) administration which induces an endogenous double peak of LH and FSH through a "flare up effect".
Miming common practice for in vitro fertilization, priming with hCG or GnRHa injection 36 hours before the COCs retrieval has been suggested for patients undergoing IVM procedure in order to improve oocyte maturation rates and further IVM outcomes.
Indeed, it is hypothesized that these iatrogenic hormonal activities might enhance the final oocyte maturation in vivo, therefore shortening the duration of the overall IVM process.
Actually, in PCOS patients, several line of evidence indicate that IVM outcomes are improved after hCG priming.
This positive effect might be explained by a premature expression of LH receptors on granulosa cells of small antral follicles <10 mm in diameter.
Nevertheless, in normo-ovulatory non PCOS patients, LH receptor expression in these follicles remains very low, questioning the relevance of providing LH activity to improve oocyte maturation during IVM cycles performed for FP.
The present investigation aimed to test whether the absence of therapeutic intervention prior to oocyte retrieval modifies IVM outcomes when compared with cycles primed either with recombinant hCG or GnRH agonist in breast cancer patients.
Study Type
Interventional
Enrollment (Anticipated)
204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charlotte Sonigo, MD, PhD
- Email: charlotte.sonigo@gmail.com
Study Contact Backup
- Name: Michael Grynberg, Prof
- Email: Michael.grynberg@aphp.fr
Study Locations
-
-
-
Bondy, France, 93140
- Recruiting
- Hôpital Jean Verdier
-
Contact:
- Michael Grynberg, Professor
- Email: Michael.grynberg@aphp.fr
-
-
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 to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- - previous chemotherapy, ovarian surgery or endometrioma;
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Without injection group
no injection used as priming
|
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
|
Active Comparator: hCG group
hCG used as priming
|
a subcutaneous injection of GnRH agonist (triptorelin, Decapeptyl, Ipsen, 0,2 mg) is performed 36 hours before oocytes retrieval
No hormonal injection before oocytes retrieval
|
Active Comparator: GnRHa group
GnRH agonist used as priming
|
a subcutaneous injection of hCG (Choriogonadotropin alpha, Ovitrelle®, Merck Serono, 250 µg) is performed 36 hours before oocytes retrieval
No hormonal injection before oocytes retrieval
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total number of mature oocytes cryopreserved
Time Frame: 4 days
|
Total number of mature oocytes obtained and cryopreserved after IVM
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of COCS recovered
Time Frame: 36 hours
|
Total number of COCs recovered after COCs retrieval
|
36 hours
|
maturation rate
Time Frame: 4 days
|
ratio between the number of mature oocytes over the number of COCs recovered
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
September 9, 2014
Primary Completion (Anticipated)
September 9, 2019
Study Completion (Anticipated)
October 9, 2019
Study Registration Dates
First Submitted
May 16, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 17, 2019
Study Record Updates
Last Update Posted (Actual)
May 20, 2019
Last Update Submitted That Met QC Criteria
May 16, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-A00819-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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