Primary Ovarian InsufficiencyNCT03021915
Single Center, Prospective Controlled Pilot Study of the OvaPrime Procedure
A study testing OvaPrime Treatment in people with Primary Ovarian Insufficiency and Poor Ovarian Response, run by OvaScience, Inc. at 1 site in Canada.
Trial summary
This is a single center, prospective, controlled pilot safety research study. The primary objective of this research study is to assess the safety with the use of the OvaPrime procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor ovarian response (POR). Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Primary Ovarian Insufficiency, Poor Ovarian Response
- What is being tested?
- OvaPrime Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who are diagnosed with EITHER POI or POR as defined below:
- POI subjects who are:
- < 40 years of age
- have non-detectable AMH
- FSH >15.0 mIU/ml and/or symptoms of menopause
- POR (based on European Society of Human Reproduction and Embryology (ESHRE) guidelines must have two of the following:
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- 40 years of age
- A previous IVF cycle with < 3 oocytes with a standard of care controlled ovarian hyperstimulation protocol
- An abnormal ovarian reserve test defined as:
- AFC < 5 - 7 follicles or
- AMH < 0.5 - 1.1 ng/ml or
- Highest ever baseline FSH > 15.0 ml U/ml
- Subject must have both ovaries.
- Subject agrees to participate in main study follow up as well as Long Term Follow-up (LTFU) sub-study
- Subject's male partner or sperm donor source must meet the following requirements:
- Semen must be an ejaculate (not surgically derived, epididymal, testicular, electro- ejaculated sperm), collected by ejaculation.
- Male partner's testes must not have been exposed to chemotherapy.
- Semen must have some morphologically normal spermatozoa according to the World Health Organization (see table below) and adequate concentration with some motile spermatozoa for insemination of all oocytes by intra-cytoplasmic sperm injection (ICSI).
- WHO Semen variable 2010 Volume (mL) 1.5 Concentration (106 mL-1) 15 Total sperm number (106/ejaculate) 39 Motility (% motile) 40 (a + b + c) Forward progression 32 (a + b) Morphology (% normal) 4 Viability/vitality (% live) 58 White blood cells (106 mL-1) < 1.0
- Partner must also agree to all research study requirements including follow up (including main study as well as LTFU sub-study) of offspring and sign consent form (not applicable in the case of a woman using sperm donation).
Who cannot join
- Subject with a diagnosis of POI who is ≥ 40 years of age or < 21 years of age at the time of the OvaPrime procedure
- Subject with onset of POI < 18 years of age
- Subject with a diagnosis of POR who is > 45 years of age at the time of the OvaPrime procedure
- Subject has had any prior surgery/medical condition that would prevent direct access to the ovaries (e.g., pelvic adhesions, tubo- ovarian adhesions location/displacement of the ovary(ies) or high body mass index (BMI)).
- Subject has severe (stage IV) endometriosis or presence of an endometrioma
- Subject has a unilateral or bilateral untreated hydrosalpinx
Show all 10Show fewer
- Subject has participated in the active phase of another investigational trial within the previous 30 days
- Subject has a history of prior chemotherapy or radiation therapy to the pelvis
- Subjects and/or partner (supplying sperm) with known karyotypic abnormalities 10. Subjects with POI who have FMR1 premutations or an FMRI mutation
- 11. Subjects who are positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Trial locations and contacts
1 site in 1 country.
About this study
This is a single center, prospective, controlled pilot safety research study. The primary objective of this research study is to assess the safety with the use of the OvaPrime procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor ovarian response (POR).
A maximum of ninety-five (95) subjects will be enrolled consisting of a minimum of thirty (30) POI subjects and a minimum of fifty (50) POR to achieve the target sample size of 70 Modified Intent-to-Treat (mITT) subjects as the primary analysis population. Each subject shall have one ovary exposed to the EggPC cells while the contralateral ovary is exposed to the EggPC vehicle as a means to have each subject serve as their own control. Results between the treatment and control ovary will be examined for relevant endpoints such as antral follicle counts.
The duration of the research study is estimated at approximately 6 years total, for the period spanning enrollment (estimated at approximately six months), eight months to the last hyperstimulation and through completion of 5-year follow-up (main study protocol with one year primary endpoint and LTFU sub-study which extends to 5 additional years).
- Being tested
- OvaPrime Treatment
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvaPrime TreatmentOther
The treatment is based on identified EggPC cells in the outer-most layer of the ovary. During OvaPrime, the EggPC cells are isolated from biopsy tissue obtained from the outer layer of the ovary. OvaScience separates the EggPC cells and these isolated cells are then returned to the IVF clinic - there is no culture or expansion of the EggPC cells during this process. Upon receipt of the autologous EggPC cells, the clinic initiates the process of reintroducing the cells into the follicular development zone of the woman's own ovary using a laparoscopic procedure. Once in the ovary, the EggPC cells have the opportunity to develop and mature into fertilizable eggs naturally or with controlled ovarian hyperstimulation (when stimulated by exogenous gonadotropins) using standard IVF protocols.
| Study group | Role | What they receive |
|---|---|---|
| OvaPrime Treatment | Other | The treatment is based on identified EggPC cells in the outer-most layer of the ovary. During OvaPrime, the EggPC cells are isolated from biopsy tissue obtained from the outer layer of the ovary. OvaScience separates the EggPC cells and these isolated cells are then returned to the IVF clinic - there is no culture or expansion of the EggPC cells during this process. Upon receipt of the autologous EggPC cells, the clinic initiates the process of reintroducing the cells into the follicular development zone of the woman's own ovary using a laparoscopic procedure. Once in the ovary, the EggPC cells have the opportunity to develop and mature into fertilizable eggs naturally or with controlled ovarian hyperstimulation (when stimulated by exogenous gonadotropins) using standard IVF protocols. Receives: Other: OvaPrime Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - to evaluate the frequency of adverse events (AE) and serious adverse events (SAE) of all subjects regardless of pregnancy.
For subjects who fail to achieve pregnancy, they will be assessed for one year from the date of the OvaPrime procedure. For subjects who become pregnant, they will be followed through the pregnancy and 1-year post-partum. The safety of the off-spring will be monitored by this research study up to one-year post delivery in the main study and for up to 5 years in the long-term follow-up study.
Measured: 2 years
Secondary outcomes (10)
Hormone level change from baseline in the following: anti-mullerian hormone level (AMH), follicle stimulating hormone (FSH) and estradiol (E2)
Measured: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by decreasing serum FSH
Measured: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by increasing serum AMH
Measured: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by the presence of new basal antral follicles on ultrasound
Measured: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by increasing serum E2
Measured: 1 year
Egg maturation and developmental potential as evidenced by: Number of MII eggs as assessed by embryologist.
Measured: 1 year
Egg maturation and developmental potential as evidenced by: Number of embryos on Day 5 that are graded 3BB or greater as assessed by embryologist
Measured: 1 year
Egg maturation and developmental potential as evidenced by: Number of embryo transfers
Measured: 1 year
Pre-implantation Genetic Screening (PGS) results
Measured: 1 year
The occurrence of pregnancy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: OvaScience, Inc. is no longer study sponsor as it is undergoing a merger. Follow-up will be conducted by sponsor-investigator Dr. Bob Casper.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- OvaScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Nayot, MD, Principal investigator, TRIO Fertility Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021915
- Sponsor's protocol ID
- CL-P01
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2016
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Prospective Controlled Pilot Study of the OvaPrime Procedure
- ClinicalTrials.gov ID
- NCT03021915
- Acronym / sponsor ID
- CL-P01
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: OvaScience, Inc. is no longer study sponsor as it is undergoing a merger. Follow-up will be conducted by sponsor-investigator Dr. Bob Casper.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- OvaScience, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- 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.
This is a single center, prospective, controlled pilot safety research study. The primary objective of this research study is to assess the safety with the use of the OvaPrime procedure in women who are diagnosed with either primary ovarian insufficiency (POI) or poor ovarian response (POR).
A maximum of ninety-five (95) subjects will be enrolled consisting of a minimum of thirty (30) POI subjects and a minimum of fifty (50) POR to achieve the target sample size of 70 Modified Intent-to-Treat (mITT) subjects as the primary analysis population. Each subject shall have one ovary exposed to the EggPC cells while the contralateral ovary is exposed to the EggPC vehicle as a means to have each subject serve as their own control. Results between the treatment and control ovary will be examined for relevant endpoints such as antral follicle counts.
The duration of the research study is estimated at approximately 6 years total, for the period spanning enrollment (estimated at approximately six months), eight months to the last hyperstimulation and through completion of 5-year follow-up (main study protocol with one year primary endpoint and LTFU sub-study which extends to 5 additional years).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OvaPrime Treatment | Other | Other: OvaPrime TreatmentThe treatment is based on identified EggPC cells in the outer-most layer of the ovary. During OvaPrime, the EggPC cells are isolated from biopsy tissue obtained from the outer layer of the ovary. OvaScience separates the EggPC cells and these isolated cells are then returned to the IVF clinic - there is no culture or expansion of the EggPC cells during this process. Upon receipt of the autologous EggPC cells, the clinic initiates the process of reintroducing the cells into the follicular development zone of the woman's own ovary using a laparoscopic procedure. Once in the ovary, the EggPC cells have the opportunity to develop and mature into fertilizable eggs naturally or with controlled ovarian hyperstimulation (when stimulated by exogenous gonadotropins) using standard IVF protocols. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Subjects who are diagnosed with EITHER POI or POR as defined below:
- Subject must have both ovaries.
- Subject agrees to participate in main study follow up as well as Long Term Follow-up (LTFU) sub-study
- Subject's male partner or sperm donor source must meet the following requirements:
- WHO Semen variable 2010 Volume (mL) 1.5 Concentration (106 mL-1) 15 Total sperm number (106/ejaculate) 39 Motility (% motile) 40 (a + b + c) Forward progression 32 (a + b) Morphology (% normal) 4 Viability/vitality (% live) 58 White blood cells (106 mL-1) < 1.0
Key exclusion criteria (10 listed)
- Subject with a diagnosis of POI who is ≥ 40 years of age or < 21 years of age at the time of the OvaPrime procedure
- Subject with onset of POI < 18 years of age
- Subject with a diagnosis of POR who is > 45 years of age at the time of the OvaPrime procedure
- Subject has had any prior surgery/medical condition that would prevent direct access to the ovaries (e.g., pelvic adhesions, tubo- ovarian adhesions location/displacement of the ovary(ies) or high body mass index (BMI)).
- Subject has severe (stage IV) endometriosis or presence of an endometrioma
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 |
|---|---|---|
| OvaPrime TreatmentThe treatment is based on identified EggPC cells in the outer-most layer of the ovary. During OvaPrime, the EggPC cells are isolated from biopsy tissue obtained from the outer layer of the ovary. OvaScience separates the EggPC cells and these isolated cells are then returned to the IVF clinic - there is no culture or expansion of the EggPC cells during this process. Upon receipt of the autologous EggPC cells, the clinic initiates the process of reintroducing the cells into the follicular development zone of the woman's own ovary using a laparoscopic procedure. Once in the ovary, the EggPC cells have the opportunity to develop and mature into fertilizable eggs naturally or with controlled ovarian hyperstimulation (when stimulated by exogenous gonadotropins) using standard IVF protocols. | Other | OvaPrime Treatment |
Primary outcome
Safety - to evaluate the frequency of adverse events (AE) and serious adverse events (SAE) of all subjects regardless of pregnancy.
Time frame: 2 years
For subjects who fail to achieve pregnancy, they will be assessed for one year from the date of the OvaPrime procedure. For subjects who become pregnant, they will be followed through the pregnancy and 1-year post-partum. The safety of the off-spring will be monitored by this research study up to one-year post delivery in the main study and for up to 5 years in the long-term follow-up study.
10 secondary outcomes
Hormone level change from baseline in the following: anti-mullerian hormone level (AMH), follicle stimulating hormone (FSH) and estradiol (E2)
Time frame: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by decreasing serum FSH
Time frame: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by increasing serum AMH
Time frame: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by the presence of new basal antral follicles on ultrasound
Time frame: 1 year
Development of new primordial or growing follicles in the treated ovary as determined by increasing serum E2
Time frame: 1 year
Egg maturation and developmental potential as evidenced by: Number of MII eggs as assessed by embryologist.
Time frame: 1 year
Egg maturation and developmental potential as evidenced by: Number of embryos on Day 5 that are graded 3BB or greater as assessed by embryologist
Time frame: 1 year
Egg maturation and developmental potential as evidenced by: Number of embryo transfers
Time frame: 1 year
Pre-implantation Genetic Screening (PGS) results
Time frame: 1 year
The occurrence of pregnancy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dan Nayot, MD principal investigator
TRIO Fertility Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OvaPrime Treatment in people with Primary Ovarian Insufficiency and Poor Ovarian Response, run by OvaScience, Inc. at 1 site in Canada.
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 20 inclusion and 10 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: paused, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - to evaluate the frequency of adverse events (AE) and serious adverse events (SAE) of all subjects regardless of pregnancy. (time frame: 2 years). 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 28 Nov 2018.