Fertility PreservationPhase 3NCT06227949
FSH and LH Versus FSH Alone for Ovarian Stimulation in Non-hormone Sensitive Onco-fertility Patients
A Phase 3 study testing Luveris in people with Fertility Preservation, run by Ellen Greenblatt.
Trial summary
Fertility preservation has been performed before the initiation of cancer therapy as cancer therapy is known to be toxic for ovarian function. However, recent studies have shown that ovarian function is reduced in cancer patients even before they start cancer therapy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fertility Preservation
- What is being tested?
- Luveris
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18 and 40.
- Undergoing IVF for fertility preservation (freezing all oocytes or embryos)
- Diagnosed with a non-hormone sensitive malignancy (malignancy other than breast, uterine and ovarian cancer)
- GnRH antagonist protocol (standard of care for all fertility preservation patients)
Who cannot join
- Any contraindication to treatment with gonadotropins (including medical history or risk factors for TE, hypersensitivity to gonadotropins or to any of the excipients).
- Congenital hypogonadotropic hypogonadism unrelated to the oncological condition.
- Previous adverse or allergic reaction to luteinizing hormone or any of its drug components.
- Had prior radiotherapy to the abdomen or pelvis
- Prior chemotherapy
- Prior history of deep vein thrombosis, or pulmonary embolism
Show all 12Show fewer
- Patients with a diagnosis of hormone sensitive cancer including ovarian, uterine, or mammary carcinoma
- Patients with uncontrolled thyroid or adrenal failure
- Patients with active, untreated tumors of the hypothalamus and pituitary gland
- Patients who are lactating
- Patients with a known diagnosis of primary ovarian failure
- Previous participant of this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FSH and LH Versus FSH Alone for Ovarian Stimulation in Non-hormone Sensitive Onco-fertility Patients: an Exploratory Randomized Controlled Trial
Fertility preservation has been performed before the initiation of cancer therapy as cancer therapy is known to be toxic for ovarian function. However, recent studies have shown that ovarian function is reduced in cancer patients even before they start cancer therapy. Reduced ovarian function has been shown by these patients having fewer mature oocytes (female eggs) and lower peak levels of estradiol (a type of estrogen hormone important for fertility). Other studies have shown that in some types of cancers, cancer patients have lower levels of anti-Müllerian hormone, which is a hormone measured to assess how many eggs patient has remaining in the body. Because of these poorer fertility markers shown in cancer patients prior to therapy, some doctors and researchers believe that alternative medications for stimulating ovaries may prove to be beneficial for stimulating the ovaries during fertility preservation.
Currently, luteinizing hormone injections are approved by Health Canada for patients with hypothalamic dysfunction. Hypothalamic dysfunction is a condition whereby lower levels of fertility hormones are produced because of brain dysfunction. Other reasons luteinizing hormone is used in clinical practice is in patients with poor ovarian reserve and patients who are older.
Read more
Recent research studies have suggested that some oncology patients may be poor responders prior to cancer therapy because of their underlying disease. The exact reasons for this poor response are not known. However, some researchers believe it may be related to the interactions between the brain and fertility organs, similar to patients with hypothalamic dysfunction. Because of this possible similarity to patients with hypothalamic dysfunction, adding luteinizing hormone to follicle-stimulating hormone (the hormone typically used for ovarian stimulation) may be beneficial for fertility preservation. Studies have also shown improved fertility outcomes with the addition of luteinizing hormone in non-cancer patients who were previously known to be poor responders to ovarian stimulation.
The clinical trial team is aiming to conduct a randomized controlled trial to evaluate the safety and efficacy of luteinizing hormone in non-hormone sensitive cancer patients (patients with cancer other than the breast, ovary or uterus).
Read the detailed description
The proposed study is a superiority, randomized controlled trial examining the effect of FSH and rLH (Luveris) versus FSH alone on the number of mature oocytes available for cryopreservation in non-hormone sensitive onco-fertility patients. These patients include those diagnosed with malignancy other than breast, uterine and ovarian cancer.
Given that the care of oncology patients is time sensitive, a random start of the treatment cycle is the usual approach in Mount Sinai Fertility clinic, with no prior priming. The patient has a random serum levels of estrogen, progesterone, LH, FSH and HCG levels. A transvaginal ultrasound is performed as well, and the stage of the cycle is determined. Based on the stage of the cycle, gonadotropin starting time is planned accordingly.
- Early follicular phase: Gonadotropin stimulation started. A GnRH antagonist will be given once the dominant follicle measures >1.4 cm.
- Mid to late follicular phase: patients who have a dominant follicle >1.5 cm with an E2 >300 and a progesterone <5 will be triggered usually with HCG (Ovidrel 250 mcg subcutaneous). After three days gonadotropin stimulation is started.
- Start of luteal phase: start gonadotropin stimulation and once the dominant follicle measure >1.4, a GnRH antagonist will be given.
Patients will be randomly assigned in a 1:1 ratio to either treatment or control group. Treatments in each of the trial arms will be as follows:
- Treatment arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) in addition to Luveris daily until a pre-set criteria to trigger ovulation is reached.
- Control arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached.
Transvaginal ultrasound and bloodwork monitoring is initiated to monitor the ovarian response.
Once the patient meets one of the following two criteria
- A serum estradiol (E2) of greater than 2,000 pmol/L
- A follicle measuring greater than 14 mm,
A daily, subcutaneous injection of a GnRH antagonist (Cetrotide or Ganirelix 0.25 mg) will be administered by the patient subcutaneously to prevent an endogenous surge in LH. Monitoring of the ovarian response will continue until there are 3 or more follicles visualized by transvaginal ultrasound with a mean diameter of ≥17 mm. Ovulation will be subsequently triggered with a subcutaneous injection of HCG or GnRH agonist depending on the managing IVF physician. Twelve hours after their trigger medication, patients will return to the clinic for standard blood work including LH and progesterone. This is a standard confirmatory blood test to confirm that an endogenous LH surge has occurred. In approximately less than 5% of cases, the GnRH-a trigger fails to elicit an optimal surge, which may require a "rescue" low-dose hCG trigger to be administered 24 hours following the initial trigger. The decision to administer a "rescue" trigger will be at the discretion of the managing IVF physician. Transvaginal, ultrasound-guided oocyte retrieval will be performed approximately 36 hours following the administration of the initial trigger.
Once the oocytes are retrieved, the availability of sperm will determine whether the partner's sperm or donor sperm will be used. If the patient desires to cryopreserve oocytes, mature oocytes will be cryopreserved by vitrification process. If embryo cryopreservation is planned, the retrieved oocytes will be fertilized in the lab using traditional IVF or ICSI. Embryos will be grown to day 5 and all "good quality" blastocysts will be cryopreserved using vitrification. At Mount Sinai Fertility clinic, day 5/6 embryos are considered "good quality" for cryopreservation if they are at least a grade 2BB (or above) on day 5 and/or a 3CC (or above) on day 6, according to the classification system by Gardner and Schoolcraft, 1999. Patients will undergo a freeze-all cycle, with no fresh transfer of embryos.
The primary outcome measure will be the total number of mature (MII) oocytes available for cryopreservation.
Secondary outcome measures will include the following:
- Total number of oocytes retrieved per cycle
- Ratio of mature (MII) to immature oocytes
- Total number of mature oocytes (MII) retrieved per IVF/ICSI cycle
- Ratio of mature (MII) to immature oocytes per IVF/ICSI cycle
- Number of two pronuclei (2PN) zygotes
- Fertilization rate, which will include two outcomes each defined as follows:
Definition 1: number of 2PN zygotes divided by the number of mature oocyte(s) fertilized per IVF/ICSI cycle.
Definition 2: number of 2PN zygotes divided by the number of oocytes incubated with at least 10,000 sperm per IVF cycle.
- Total number of day 3 embryos
- Total number of good quality day 5 embryos available for cryopreservation determined by a blinded embryologist using the classification system by Gardner and Schoolcraft, 1999.
- Incidence of moderate to critical OHSS based on the classification criteria by Mathur et al. 2005
- Conditions
- Fertility Preservation
- Being tested
- Luveris
- Keywords
- IVF, fertility preservation, oncofertility, rLH, FSH, cryopreservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuverisDrug
Patients will self-administer a subcutaneous injection of Luveris in addition to Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | subcutaneous injection of Gonal-F (FSH) |
| Intervention | Experimental | subcutaneous injection of Luveris in addition to Gonal-F (FSH) Receives: Drug: Luveris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of mature (MII) oocytes available for cryopreservation
Measured: 12hrs after egg retrieval
Secondary outcomes (9)
Total number of oocytes retrieved per cycle
Measured: 1hr after egg retrieval
Ratio of mature (MII) to immature oocytes
Measured: 12 hours after egg retrieval
Total number of mature oocytes (MII) retrieved per IVF/ICSI cycle
Measured: 12 hours after egg retrieval
Ratio of mature (MII) to immature oocytes per IVF/ICSI cycle
Measured: 12 hours after egg retrieval
Number of two pronuclei (2PN) zygotes
Measured: 48 hours after egg retrieval
Fertilization rate, which will include two outcomes each defined as follows:
- Definition 1: number of 2PN zygotes divided by the number of mature oocyte(s) fertilized per IVF/ICSI cycle.
- Definition 2: number of 2PN zygotes divided by the number of oocytes incubated with at least 10,000 sperm per IVF cycle.
Measured: 48 hours after egg retrieval
Total number of day 3 embryos
Measured: 72-80 hours after egg retrieval
Total number of good quality day 5 embryos available for cryopreservation determined by a blinded embryologist using the classification system by Gardner and Schoolcraft, 1999.
Measured: 120-132 hours after egg retrieval
Incidence of moderate to critical OHSS based on the classification criteria by Mathur et al. 2005
Measured: 2 weeks after egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned in a 1:1 ratio to either treatment or control group. Treatments in each of the trial arms will be as follows: 1. Treatment arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) in addition to Luveris daily until a pre-set criteria to trigger ovulation is reached. 2. Control arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ellen Greenblatt
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Sponsor-investigator, Ellen Greenblatt, Mount Sinai Hospital, Canada
- Investigators
- Ellen Greenblatt, MD FRCSC, Principal investigator, Mount Sinai Fertility, Mount Sinai Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227949
- Sponsor's protocol ID
- MS200061_0066
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD datasets that underlie results in the publication will be shared, including study protocol, statistical analysis plan, and clinical study plan.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FSH and LH Versus FSH Alone for Ovarian Stimulation in Non-hormone Sensitive Onco-fertility Patients: an Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06227949
- Acronym / sponsor ID
- MS200061_0066
- Conditions
- Fertility Preservation
- Keywords
- IVF, fertility preservation, oncofertility, rLH, FSH, cryopreservation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ellen GreenblattUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fertility preservation has been performed before the initiation of cancer therapy as cancer therapy is known to be toxic for ovarian function. However, recent studies have shown that ovarian function is reduced in cancer patients even before they start cancer therapy. Reduced ovarian function has been shown by these patients having fewer mature oocytes (female eggs) and lower peak levels of estradiol (a type of estrogen hormone important for fertility). Other studies have shown that in some types of cancers, cancer patients have lower levels of anti-Müllerian hormone, which is a hormone measured to assess how many eggs patient has remaining in the body. Because of these poorer fertility markers shown in cancer patients prior to therapy, some doctors and researchers believe that alternative medications for stimulating ovaries may prove to be beneficial for stimulating the ovaries during fertility preservation.
Currently, luteinizing hormone injections are approved by Health Canada for patients with hypothalamic dysfunction. Hypothalamic dysfunction is a condition whereby lower levels of fertility hormones are produced because of brain dysfunction. Other reasons luteinizing hormone is used in clinical practice is in patients with poor ovarian reserve and patients who are older.
Recent research studies have suggested that some oncology patients may be poor responders prior to cancer therapy because of their underlying disease. The exact reasons for this poor response are not known. However, some researchers believe it may be related to the interactions between the brain and fertility organs, similar to patients with hypothalamic dysfunction. Because of this possible similarity to patients with hypothalamic dysfunction, adding luteinizing hormone to follicle-stimulating hormone (the hormone typically used for ovarian stimulation) may be beneficial for fertility preservation. Studies have also shown improved fertility outcomes with the addition of luteinizing hormone in non-cancer patients who were previously known to be poor responders to ovarian stimulation.
The clinical trial team is aiming to conduct a randomized controlled trial to evaluate the safety and efficacy of luteinizing hormone in non-hormone sensitive cancer patients (patients with cancer other than the breast, ovary or uterus).
Detailed description
The proposed study is a superiority, randomized controlled trial examining the effect of FSH and rLH (Luveris) versus FSH alone on the number of mature oocytes available for cryopreservation in non-hormone sensitive onco-fertility patients. These patients include those diagnosed with malignancy other than breast, uterine and ovarian cancer.
Given that the care of oncology patients is time sensitive, a random start of the treatment cycle is the usual approach in Mount Sinai Fertility clinic, with no prior priming. The patient has a random serum levels of estrogen, progesterone, LH, FSH and HCG levels. A transvaginal ultrasound is performed as well, and the stage of the cycle is determined. Based on the stage of the cycle, gonadotropin starting time is planned accordingly.
- Early follicular phase: Gonadotropin stimulation started. A GnRH antagonist will be given once the dominant follicle measures >1.4 cm.
- Mid to late follicular phase: patients who have a dominant follicle >1.5 cm with an E2 >300 and a progesterone <5 will be triggered usually with HCG (Ovidrel 250 mcg subcutaneous). After three days gonadotropin stimulation is started.
- Start of luteal phase: start gonadotropin stimulation and once the dominant follicle measure >1.4, a GnRH antagonist will be given.
Patients will be randomly assigned in a 1:1 ratio to either treatment or control group. Treatments in each of the trial arms will be as follows:
- Treatment arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) in addition to Luveris daily until a pre-set criteria to trigger ovulation is reached.
- Control arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached.
Transvaginal ultrasound and bloodwork monitoring is initiated to monitor the ovarian response.
Once the patient meets one of the following two criteria
- A serum estradiol (E2) of greater than 2,000 pmol/L
- A follicle measuring greater than 14 mm,
A daily, subcutaneous injection of a GnRH antagonist (Cetrotide or Ganirelix 0.25 mg) will be administered by the patient subcutaneously to prevent an endogenous surge in LH. Monitoring of the ovarian response will continue until there are 3 or more follicles visualized by transvaginal ultrasound with a mean diameter of ≥17 mm. Ovulation will be subsequently triggered with a subcutaneous injection of HCG or GnRH agonist depending on the managing IVF physician. Twelve hours after their trigger medication, patients will return to the clinic for standard blood work including LH and progesterone. This is a standard confirmatory blood test to confirm that an endogenous LH surge has occurred. In approximately less than 5% of cases, the GnRH-a trigger fails to elicit an optimal surge, which may require a "rescue" low-dose hCG trigger to be administered 24 hours following the initial trigger. The decision to administer a "rescue" trigger will be at the discretion of the managing IVF physician. Transvaginal, ultrasound-guided oocyte retrieval will be performed approximately 36 hours following the administration of the initial trigger.
Once the oocytes are retrieved, the availability of sperm will determine whether the partner's sperm or donor sperm will be used. If the patient desires to cryopreserve oocytes, mature oocytes will be cryopreserved by vitrification process. If embryo cryopreservation is planned, the retrieved oocytes will be fertilized in the lab using traditional IVF or ICSI. Embryos will be grown to day 5 and all "good quality" blastocysts will be cryopreserved using vitrification. At Mount Sinai Fertility clinic, day 5/6 embryos are considered "good quality" for cryopreservation if they are at least a grade 2BB (or above) on day 5 and/or a 3CC (or above) on day 6, according to the classification system by Gardner and Schoolcraft, 1999. Patients will undergo a freeze-all cycle, with no fresh transfer of embryos.
The primary outcome measure will be the total number of mature (MII) oocytes available for cryopreservation.
Secondary outcome measures will include the following:
- Total number of oocytes retrieved per cycle
- Ratio of mature (MII) to immature oocytes
- Total number of mature oocytes (MII) retrieved per IVF/ICSI cycle
- Ratio of mature (MII) to immature oocytes per IVF/ICSI cycle
- Number of two pronuclei (2PN) zygotes
- Fertilization rate, which will include two outcomes each defined as follows:
Definition 1: number of 2PN zygotes divided by the number of mature oocyte(s) fertilized per IVF/ICSI cycle.
Definition 2: number of 2PN zygotes divided by the number of oocytes incubated with at least 10,000 sperm per IVF cycle.
- Total number of day 3 embryos
- Total number of good quality day 5 embryos available for cryopreservation determined by a blinded embryologist using the classification system by Gardner and Schoolcraft, 1999.
- Incidence of moderate to critical OHSS based on the classification criteria by Mathur et al. 2005
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned in a 1:1 ratio to either treatment or control group. Treatments in each of the trial arms will be as follows: 1. Treatment arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) in addition to Luveris daily until a pre-set criteria to trigger ovulation is reached. 2. Control arm: Patients will self-administer a subcutaneous injection of Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –subcutaneous injection of Gonal-F (FSH) |
| Intervention | Experimental | Drug: Luverissubcutaneous injection of Luveris in addition to Gonal-F (FSH) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 40.
- Undergoing IVF for fertility preservation (freezing all oocytes or embryos)
- Diagnosed with a non-hormone sensitive malignancy (malignancy other than breast, uterine and ovarian cancer)
- GnRH antagonist protocol (standard of care for all fertility preservation patients)
Key exclusion criteria (12 listed)
- Any contraindication to treatment with gonadotropins (including medical history or risk factors for TE, hypersensitivity to gonadotropins or to any of the excipients).
- Congenital hypogonadotropic hypogonadism unrelated to the oncological condition.
- Previous adverse or allergic reaction to luteinizing hormone or any of its drug components.
- Had prior radiotherapy to the abdomen or pelvis
- Prior chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuverisPatients will self-administer a subcutaneous injection of Luveris in addition to Gonal-F (FSH) daily until a pre-set criteria to trigger ovulation is reached. | Drug | Intervention |
Primary outcome
Total number of mature (MII) oocytes available for cryopreservation
Time frame: 12hrs after egg retrieval
9 secondary outcomes
Total number of oocytes retrieved per cycle
Time frame: 1hr after egg retrieval
Ratio of mature (MII) to immature oocytes
Time frame: 12 hours after egg retrieval
Total number of mature oocytes (MII) retrieved per IVF/ICSI cycle
Time frame: 12 hours after egg retrieval
Ratio of mature (MII) to immature oocytes per IVF/ICSI cycle
Time frame: 12 hours after egg retrieval
Number of two pronuclei (2PN) zygotes
Time frame: 48 hours after egg retrieval
Fertilization rate, which will include two outcomes each defined as follows:
Time frame: 48 hours after egg retrieval
Total number of day 3 embryos
Time frame: 72-80 hours after egg retrieval
Total number of good quality day 5 embryos available for cryopreservation determined by a blinded embryologist using the classification system by Gardner and Schoolcraft, 1999.
Time frame: 120-132 hours after egg retrieval
Incidence of moderate to critical OHSS based on the classification criteria by Mathur et al. 2005
Time frame: 2 weeks after egg retrieval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: Yes. All IPD datasets that underlie results in the publication will be shared, including study protocol, statistical analysis plan, and clinical study plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen Greenblatt, MD FRCSC principal investigator
Mount Sinai Fertility, Mount Sinai Hospital, University of Toronto
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Luveris in people with Fertility Preservation, run by Ellen Greenblatt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen Greenblatt, MD FRCSC (416 596 5046, ellen.greenblatt@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of mature (MII) oocytes available for cryopreservation (time frame: 12hrs after egg retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.