Ovarian ReserveNCT02240342
Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve
A study testing Bone marrow transplant into ovarian artery in people with Ovarian Reserve, run by Hospital Universitario La Fe at 1 site in Spain.
Trial summary
Women delay maternity and, as a consequence, available oocyte number and their quality decrease (9-18% of all IVF patients). Different treatment protocols have been developed nevertheless none of them optimal: the number of oocytes retrieved depends on the present ones. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Reserve
- What is being tested?
- Bone marrow transplant into ovarian artery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Mar 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- < or= 40 years old
- FSH<15UI/L
- poor ovarian response after controlled ovarian stimulation with conventional doses (<3 oocytes) or two episodes of poor ovarian response after ovarian stimulation with maximal doses even if young or normal ovarian reserve study.
- Antral follicle count>2
- >1 antral follicle in the perfused ovary
- AMH between 0,5 and 3pmol/L
- regular menstrual bleeding each 21-35 days
- To be candidate to autologous hematopoietic progenitors transplantation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La fe
Valencia, Valencia, 46026
Susana Martínez, Doctor, +34961244000 ext. 244116, susamc12@hotmail.com
Mónica Romeu, Doctor, +34961244000 ext. 244116, monicaromeuvillarroya@gmail.com
About this study
Official title: Ovarian Rejuvenation: Regeneration of Ovarian Follicles in Women With Poor Ovarian Reserve by Autologous Transplantation of Bone Marrow Derived Progenitors Cells in Peripheral Blood. Pilot Study.
Women delay maternity and, as a consequence, available oocyte number and their quality decrease (9-18% of all IVF patients). Different treatment protocols have been developed nevertheless none of them optimal: the number of oocytes retrieved depends on the present ones. New generation of oocytes and follicles has been defended by some authors and bone marrow seems to be involved. What seems crucial is the niche that produces paracrine signals able to activate dormant cells and to attract undifferentiated cells from other tissues (homing). This phenomenon has been described by our group in other human reproductive tissues like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women with poor ovarian reserve by means of bone marrow protective capacity.
Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to colonize ovarian niche.
The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve differentiating themselves into germ cells or, more likely, stimulating the niche to activate dormant follicles.
- Conditions
- Ovarian Reserve
- Being tested
- Bone marrow transplant into ovarian artery
- Keywords
- Ovarian reserve, Poor response, Follicle recruitment, Bone marrow transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow transplant into ovarian arteryDrug
Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery
| Study group | Role | What they receive |
|---|---|---|
| Poor ovarian reserve women | Experimental | Not described Receives: Drug: Bone marrow transplant into ovarian artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve
Measured by FSH-LH, oestradiol, AMH, antral follicle count
Measured: 6 months
Secondary outcomes (1)
Ovarian response to controlled ovarian stimulation
Number of MII oocytes obtained
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2016 (estimated)
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 Ovarian ReserveStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio Pellicer Martínez, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240342
- Sponsor's protocol ID
- NEOFOL2014
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Herraiz S, Romeu M, Buigues A, Martinez S, Diaz-Garcia C, Gomez-Segui I, Martinez J, Pellicer N, Pellicer A. Autologous stem cell ovarian transplantation to increase reproductive potential in patients who are poor responders. Fertil Steril. 2018 Aug;110(3):496-505.e1. doi: 10.1016/j.fertnstert.2018.04.025. Epub 2018 Jun 28.
PubMed 29960701Herraiz S, Buigues A, Diaz-Garcia C, Romeu M, Martinez S, Gomez-Segui I, Simon C, Hsueh AJ, Pellicer A. Fertility rescue and ovarian follicle growth promotion by bone marrow stem cell infusion. Fertil Steril. 2018 May;109(5):908-918.e2. doi: 10.1016/j.fertnstert.2018.01.004. Epub 2018 Mar 22.
PubMed 29576341
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Rejuvenation: Regeneration of Ovarian Follicles in Women With Poor Ovarian Reserve by Autologous Transplantation of Bone Marrow Derived Progenitors Cells in Peripheral Blood. Pilot Study.
- ClinicalTrials.gov ID
- NCT02240342
- Acronym / sponsor ID
- NEOFOL2014
- Conditions
- Ovarian Reserve
- Keywords
- Ovarian reserve, Poor response, Follicle recruitment, Bone marrow transplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 15 Sep 2014 (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.
Women delay maternity and, as a consequence, available oocyte number and their quality decrease (9-18% of all IVF patients). Different treatment protocols have been developed nevertheless none of them optimal: the number of oocytes retrieved depends on the present ones. New generation of oocytes and follicles has been defended by some authors and bone marrow seems to be involved. What seems crucial is the niche that produces paracrine signals able to activate dormant cells and to attract undifferentiated cells from other tissues (homing). This phenomenon has been described by our group in other human reproductive tissues like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women with poor ovarian reserve by means of bone marrow protective capacity.
Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to colonize ovarian niche.
The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve differentiating themselves into germ cells or, more likely, stimulating the niche to activate dormant follicles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poor ovarian reserve women | Experimental | Drug: Bone marrow transplant into ovarian artery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- < or= 40 years old
- FSH<15UI/L
- poor ovarian response after controlled ovarian stimulation with conventional doses (<3 oocytes) or two episodes of poor ovarian response after ovarian stimulation with maximal doses even if young or normal ovarian reserve study.
- Antral follicle count>2
- >1 antral follicle in the perfused ovary
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Bone marrow transplant into ovarian arteryBone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery | Drug | Poor ovarian reserve women |
Primary outcome
Ovarian reserve
Time frame: 6 months
Measured by FSH-LH, oestradiol, AMH, antral follicle count
1 secondary outcome
Ovarian response to controlled ovarian stimulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Derived from this study: PubMed 29960701Herraiz S, Romeu M, Buigues A, Martinez S, Diaz-Garcia C, Gomez-Segui I, Martinez J, Pellicer N, Pellicer A. Autologous stem cell ovarian transplantation to increase reproductive potential in patients who are poor responders. Fertil Steril. 2018 Aug;110(3):496-505.e1. doi: 10.1016/j.fertnstert.2018.04.025. Epub 2018 Jun 28.
- Derived from this study: PubMed 29576341Herraiz S, Buigues A, Diaz-Garcia C, Romeu M, Martinez S, Gomez-Segui I, Simon C, Hsueh AJ, Pellicer A. Fertility rescue and ovarian follicle growth promotion by bone marrow stem cell infusion. Fertil Steril. 2018 May;109(5):908-918.e2. doi: 10.1016/j.fertnstert.2018.01.004. Epub 2018 Mar 22.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow transplant into ovarian artery in people with Ovarian Reserve, run by Hospital Universitario La Fe at 1 site in Spain.
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 8 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: status not confirmed, as of the sponsor's last update on 15 Sep 2014. 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 Spain. 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?
Contact Antonio Pellicer, Professor (+34961244000 ext. 245848, pellicer_ant@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian reserve (time frame: 6 months). 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 NCT02240342, 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 15 Sep 2014.