Primary Ovarian InsufficiencyIVANCT02496598
In Vitro Follicle Activation
A study testing In Vitro Follicle Activation (IVA) and Follicle Activation in people with Primary Ovarian Insufficiency and Infertility, run by National Foundation for Fertility Research at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency, Infertility
- What is being tested?
- In Vitro Follicle Activation (IVA) and Follicle Activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Jul 2017
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with primary ovarian insufficiency (POI), seeking pregnancy and eligible for IVF at Colorado Center for Reproductive Medicine (Lone Tree, CO).
- Patients can be of any race, culture, sexual orientation or ethnicity.
Who cannot join
- Minors are excluded from participation in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fertility Laboratories of Colorado
Lone Tree, Colorado, 80124
National Foundation for Fertility Research
Lone Tree, Colorado, 80124
About this study
Official title: In Vitro Activation of Primordial Follicles as a Method to Treat Infertility Caused by Primary Ovarian Insufficiency
The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI).
Read the detailed description
The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI; also known as premature ovarian failure). Patients diagnosed with POI are infertile due to a lack of follicle growth and ovulation; oocyte donation is the only treatment option currently available to enable these women to have a child. IVA treatment may result in the rescue of the remaining primordial follicles within the ovary, thus making oocytes available for IVF, embryo production, transfer and pregnancy. In this experimental treatment, ovarian tissue is removed from the patient and cultured in vitro for 48 hours with specific compounds to activate dormant primordial follicles. Following activation ovarian tissue is auto-grafted to the serosa of the fallopian tube, and the patient is monitored for signs of follicle growth. Growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and IVF.
- Conditions
- Primary Ovarian Insufficiency, Infertility
- Being tested
- In Vitro Follicle Activation (IVA), Follicle Activation
- Keywords
- Reproductive Techniques, Assisted, Ovarian Follicle
- Medical subject headings
- Primary Ovarian Insufficiency, Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro Follicle Activation (IVA)Procedure or surgery
Laparoscopic removal of ovarian tissue, followed by in vitro activation of dormant ovarian follicles and autografting back to the patient for follicle growth and egg retrieval.
Follicle ActivationDrug
Ovarian cortical pieces will be treated in vitro with a PTEN activator (bpV(hopic)) and a PI3K inhibitor (740YP) in vitro to activate primordial ovarian follicles, prior to autografting.
| Study group | Role | What they receive |
|---|---|---|
| In Vitro Follicle Activation (IVA) | Experimental | Ovarian tissue will be removed and cultured in vitro with compounds to activate dormant follicles. Following activation, ovarian tissue will be auto-grafted and the patient monitored for follicular growth. Receives: Procedure: In Vitro Follicle Activation (IVA); Drug: Follicle Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral follicle development measured by ultrasound examination
Ultrasound analysis of the number of follicles developing in the grafted ovarian tissue following activation in vitro
Measured: 1 year after auto-grafting
Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration
The number of oocytes recovered from follicles developing in the grafted ovarian tissue following in vitro activation
Measured: 1 year after auto-grafting
Pregnancy
The incidence of implantation and pregnancy following transfer of embryos produced from oocytes recovered from follicles developing in the activated ovarian tissue.
Measured: 1.5 years after auto-grafting
Secondary outcomes (3)
Offspring weight
The birth weight of children born
Measured: 1 year after egg retrieval
Offspring gender
The gender of children born
Measured: 1 year after egg retrieval
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
The proportion of good quality blastocyst stage embryos developed during in vitro fertilization (IVF) cycle(s), of the total number of fertilized eggs
Measured: 1 week 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 posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Results were not promising
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Foundation for Fertility Research
- Sponsor type
- University, hospital or other
- Collaborators
- Fertility Laboratories Of Colorado
- Responsible party
- Sponsor
- Investigators
- Rebecca L Krisher, Ph.D., Principal investigator, NFFRWilliam B Schoolcraft, M.D., Principal investigator, Fertility Laboratories Of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496598
- Sponsor's protocol ID
- NFFR-IVA-2015
- Acronym
- IVA
- Status last verified
- Aug 2018
- First submitted
- 7 Jul 2015
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kawamura K, Cheng Y, Suzuki N, Deguchi M, Sato Y, Takae S, Ho CH, Kawamura N, Tamura M, Hashimoto S, Sugishita Y, Morimoto Y, Hosoi Y, Yoshioka N, Ishizuka B, Hsueh AJ. Hippo signaling disruption and Akt stimulation of ovarian follicles for infertility treatment. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17474-9. doi: 10.1073/pnas.1312830110. Epub 2013 Sep 30.
PubMed 24082083Suzuki N, Yoshioka N, Takae S, Sugishita Y, Tamura M, Hashimoto S, Morimoto Y, Kawamura K. Successful fertility preservation following ovarian tissue vitrification in patients with primary ovarian insufficiency. Hum Reprod. 2015 Mar;30(3):608-15. doi: 10.1093/humrep/deu353. Epub 2015 Jan 6.
PubMed 25567618
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Activation of Primordial Follicles as a Method to Treat Infertility Caused by Primary Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT02496598
- Acronym / sponsor ID
- IVA / NFFR-IVA-2015
- Conditions
- Primary Ovarian Insufficiency, Infertility
- Keywords
- Reproductive Techniques, Assisted, Ovarian Follicle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results were not promising
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National Foundation for Fertility ResearchUniversity, hospital or other
- Collaborators
- Fertility Laboratories Of Colorado
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Jul 2015 (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.
The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI).
Detailed description
The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI; also known as premature ovarian failure). Patients diagnosed with POI are infertile due to a lack of follicle growth and ovulation; oocyte donation is the only treatment option currently available to enable these women to have a child. IVA treatment may result in the rescue of the remaining primordial follicles within the ovary, thus making oocytes available for IVF, embryo production, transfer and pregnancy. In this experimental treatment, ovarian tissue is removed from the patient and cultured in vitro for 48 hours with specific compounds to activate dormant primordial follicles. Following activation ovarian tissue is auto-grafted to the serosa of the fallopian tube, and the patient is monitored for signs of follicle growth. Growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and IVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In Vitro Follicle Activation (IVA) | Experimental | Procedure: In Vitro Follicle Activation (IVA), Drug: Follicle ActivationOvarian tissue will be removed and cultured in vitro with compounds to activate dormant follicles. Following activation, ovarian tissue will be auto-grafted and the patient monitored for follicular growth. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women diagnosed with primary ovarian insufficiency (POI), seeking pregnancy and eligible for IVF at Colorado Center for Reproductive Medicine (Lone Tree, CO).
- Patients can be of any race, culture, sexual orientation or ethnicity.
Key exclusion criteria (1 listed)
- Minors are excluded from participation in this study.
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 |
|---|---|---|
| In Vitro Follicle Activation (IVA)Laparoscopic removal of ovarian tissue, followed by in vitro activation of dormant ovarian follicles and autografting back to the patient for follicle growth and egg retrieval. | Procedure or surgery | In Vitro Follicle Activation (IVA) |
| Follicle ActivationOvarian cortical pieces will be treated in vitro with a PTEN activator (bpV(hopic)) and a PI3K inhibitor (740YP) in vitro to activate primordial ovarian follicles, prior to autografting. | Drug | In Vitro Follicle Activation (IVA) |
Primary outcome
Antral follicle development measured by ultrasound examination
Time frame: 1 year after auto-grafting
Ultrasound analysis of the number of follicles developing in the grafted ovarian tissue following activation in vitro
Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration
Time frame: 1 year after auto-grafting
The number of oocytes recovered from follicles developing in the grafted ovarian tissue following in vitro activation
Pregnancy
Time frame: 1.5 years after auto-grafting
The incidence of implantation and pregnancy following transfer of embryos produced from oocytes recovered from follicles developing in the activated ovarian tissue.
3 secondary outcomes
Offspring weight
Time frame: 1 year after egg retrieval
Offspring gender
Time frame: 1 year after egg retrieval
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
Time frame: 1 week after egg retrieval
Results and safety
The study was stopped early (reason given: Results were not promising). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Background: PubMed 24082083Kawamura K, Cheng Y, Suzuki N, Deguchi M, Sato Y, Takae S, Ho CH, Kawamura N, Tamura M, Hashimoto S, Sugishita Y, Morimoto Y, Hosoi Y, Yoshioka N, Ishizuka B, Hsueh AJ. Hippo signaling disruption and Akt stimulation of ovarian follicles for infertility treatment. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17474-9. doi: 10.1073/pnas.1312830110. Epub 2013 Sep 30.
- Background: PubMed 25567618Suzuki N, Yoshioka N, Takae S, Sugishita Y, Tamura M, Hashimoto S, Morimoto Y, Kawamura K. Successful fertility preservation following ovarian tissue vitrification in patients with primary ovarian insufficiency. Hum Reprod. 2015 Mar;30(3):608-15. doi: 10.1093/humrep/deu353. Epub 2015 Jan 6.
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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.
Rebecca L Krisher, Ph.D. principal investigator
NFFR
William B Schoolcraft, M.D. principal investigator
Fertility Laboratories Of Colorado
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Vitro Follicle Activation (IVA) and Follicle Activation in people with Primary Ovarian Insufficiency and Infertility, run by National Foundation for Fertility Research at 2 sites in United States.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: Results were not promising). 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?
Antral follicle development measured by ultrasound examination (time frame: 1 year after auto-grafting). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496598, which also lists 2 linked publications.
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 Aug 2018.