Ovarian ReserveNCT03621683
Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
A study testing blood rich plasma platelets and Antioxidant therapy in people with Ovarian Reserve, run by Lucy Coleman at 1 site in Venezuela.
Trial summary
Two group of patients were selected. Group 1 represents 46 patients that received ovarian-biostimulation monthly for three months. Group 2 represents 32 patients that received antioxidant therapy daily for 3 months. Results are noted and analysed. Read more about this study
- Who is it for?
- Ages 38 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Reserve
- What is being tested?
- blood rich plasma platelets and Antioxidant therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteVenezuela
- Study dates
- 6 Jan 2016to 28 Aug 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 38 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 38 and 46 years
- FSH> 12 mIU
- Estradiol > 100 pg/ml
- AMH < 0.8 ng/mL
Who cannot join
- Pelvic inflammatory syndrome
- vaginal pathologies
- known history of hyperandrogenism
- diagnosed platelet disorders as adhesion
- aggregation
- disorder of thromboxane synthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
Two group of patients were selected. Group 1 represents 46 patients that received ovarian-biostimulation monthly for three months. Group 2 represents 32 patients that received antioxidant therapy daily for 3 months. Results are noted and analysed.
Both groups represent patients with procedures already ongoing, and with diagnosed poor or depleted ovarian reserve.
The analysis has been made to compare the efficacy of both procedures.
Read the detailed description
The bioestimulation group received a blood rich platelet therapy monthly for three months, with a technique developed by the laboratory. The second group of antioxidants received a combination of antioxidants monthly for three months. Both groups were compared to assess the results in terms of ovarian response (number of astral follicles, AMH levels, FSH, LH), and egg quality, embryo development, implantation rate, and successful pregnancy with healthy live birth.
- Conditions
- Ovarian Reserve
- Being tested
- blood rich plasma platelets, Antioxidant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood rich plasma plateletsProcedure or surgery
Injection of blood rich platelet into the ovaries.
Antioxidant therapyDietary supplement
Antioxidants:
Q10, DHEA, Vitamina E, Vitamin C, Omega 3
| Study group | Role | What they receive |
|---|---|---|
| ovarian bio-stimulation | Experimental | Intervention:
ovarian bio-stimulation: blood rich plasma platelets Receives: Procedure: blood rich plasma platelets; Dietary Supplement: Antioxidant therapy |
| Antioxidant therapy | Active comparator | Intervention:
antioxidants: Q10, DHEA, Vitamin E, Vitamin C, omega 3 Receives: Procedure: blood rich plasma platelets; Dietary Supplement: Antioxidant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of hormones FSH and LH directly involved with ovarian reserve
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with FSH-LH post-treatment.
Measured: 18 months
variation of AMH directly involved with ovarian reserve in both groups
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with AMH values.
Measured: 18 months
variation in recruitment of antral follicles in both groups
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with the number of astral follicles available.
Measured: 18 months
Secondary outcomes (2)
Number of good quality eggs obtained in both groups after IVF
Egg quality is evaluated in both group of women undergoing IVF after bio-stimulation or antioxidant therapy are performed
Measured: 18 months
Number and quality of fertilised eggs obtained in both groups after IVF
the number and quality of fertilised eggs is evaluated in both groups of women undergoing IVF after bio-stimulation or antioxidant therapy is performed.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start6 Jan 2016
- Primary completion10 Jan 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative study
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucy Coleman
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Lucy Coleman, Fertiaguerrevere
- Investigators
- Carmen Navarro, MD, Principal investigator, Medical staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621683
- Sponsor's protocol ID
- J298384255
- Status last verified
- Aug 2018
- First submitted
- 28 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still deciding if sharing information. It can be shared as long as it does not contain personal identification such as name, and contact details. We might share the rest of information to other scientist studying the same area of low-depleted ovarian reserve and bio-stimulation techniques.
Publications
Bhartiya D, Parte S, Patel H, Sriraman K, Zaveri K, Hinduja I. Novel Action of FSH on Stem Cells in Adult Mammalian Ovary Induces Postnatal Oogenesis and Primordial Follicle Assembly. Stem Cells Int. 2016;2016:5096596. doi: 10.1155/2016/5096596. Epub 2015 Nov 9.
PubMed 26635884Telfer EE. Germline stem cells in the postnatal mammalian ovary: a phenomenon of prosimian primates and mice? Reprod Biol Endocrinol. 2004 May 18;2:24. doi: 10.1186/1477-7827-2-24. No abstract available.
PubMed 15149546Johnson J, Canning J, Kaneko T, Pru JK, Tilly JL. Germline stem cells and follicular renewal in the postnatal mammalian ovary. Nature. 2004 Mar 11;428(6979):145-50. doi: 10.1038/nature02316.
PubMed 15014492Pan Z, Sun M, Liang X, Li J, Zhou F, Zhong Z, Zheng Y. The Controversy, Challenges, and Potential Benefits of Putative Female Germline Stem Cells Research in Mammals. Stem Cells Int. 2016;2016:1728278. doi: 10.1155/2016/1728278. Epub 2015 Dec 15.
PubMed 26788065Ozakpinar OB, Maurer AM, Ozsavci D. Ovarian stem cells: From basic to clinical applications. World J Stem Cells. 2015 May 26;7(4):757-68. doi: 10.4252/wjsc.v7.i4.757.
PubMed 26029346Diamanti-Kandarakis E, Dattilo M, Macut D, Duntas L, Gonos ES, Goulis DG, Gantenbein CK, Kapetanou M, Koukkou E, Lambrinoudaki I, Michalaki M, Eftekhari-Nader S, Pasquali R, Peppa M, Tzanela M, Vassilatou E, Vryonidou A; COMBO ENDO TEAM: 2016. MECHANISMS IN ENDOCRINOLOGY: Aging and anti-aging: a Combo-Endocrinology overview. Eur J Endocrinol. 2017 Jun;176(6):R283-R308. doi: 10.1530/EJE-16-1061. Epub 2017 Mar 6.
PubMed 28264815Gat I, Blanco Mejia S, Balakier H, Librach CL, Claessens A, Ryan EA. The use of coenzyme Q10 and DHEA during IUI and IVF cycles in patients with decreased ovarian reserve. Gynecol Endocrinol. 2016 Jul;32(7):534-7. doi: 10.3109/09513590.2015.1137095. Epub 2016 Feb 1.
PubMed 26829445Ozcan P, Ficicioglu C, Kizilkale O, Yesiladali M, Tok OE, Ozkan F, Esrefoglu M. Can Coenzyme Q10 supplementation protect the ovarian reserve against oxidative damage? J Assist Reprod Genet. 2016 Sep;33(9):1223-30. doi: 10.1007/s10815-016-0751-z. Epub 2016 Jun 3.
PubMed 27255570
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidants vs.Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve
- ClinicalTrials.gov ID
- NCT03621683
- Acronym / sponsor ID
- J298384255
- Conditions
- Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Lucy ColemanIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 8 Aug 2018 (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.
Two group of patients were selected. Group 1 represents 46 patients that received ovarian-biostimulation monthly for three months. Group 2 represents 32 patients that received antioxidant therapy daily for 3 months. Results are noted and analysed.
Both groups represent patients with procedures already ongoing, and with diagnosed poor or depleted ovarian reserve.
The analysis has been made to compare the efficacy of both procedures.
Detailed description
The bioestimulation group received a blood rich platelet therapy monthly for three months, with a technique developed by the laboratory. The second group of antioxidants received a combination of antioxidants monthly for three months. Both groups were compared to assess the results in terms of ovarian response (number of astral follicles, AMH levels, FSH, LH), and egg quality, embryo development, implantation rate, and successful pregnancy with healthy live birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective comparative study
| Arm | Type | Receives |
|---|---|---|
| ovarian bio-stimulation | Experimental | Procedure: blood rich plasma platelets, Dietary Supplement: Antioxidant therapyIntervention: ovarian bio-stimulation: blood rich plasma platelets |
| Antioxidant therapy | Active comparator | Procedure: blood rich plasma platelets, Dietary Supplement: Antioxidant therapyIntervention: antioxidants: Q10, DHEA, Vitamin E, Vitamin C, omega 3 |
Who may qualify
- Ages
- 38 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 38 and 46 years
- FSH> 12 mIU
- Estradiol > 100 pg/ml
- AMH < 0.8 ng/mL
Key exclusion criteria (6 listed)
- Pelvic inflammatory syndrome
- vaginal pathologies
- known history of hyperandrogenism
- diagnosed platelet disorders as adhesion
- aggregation
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 |
|---|---|---|
| blood rich plasma plateletsInjection of blood rich platelet into the ovaries. | Procedure or surgery | Antioxidant therapy, ovarian bio-stimulation |
| Antioxidant therapyAntioxidants: Q10, DHEA, Vitamina E, Vitamin C, Omega 3 | Dietary supplement | Antioxidant therapy, ovarian bio-stimulation |
Primary outcome
variation of hormones FSH and LH directly involved with ovarian reserve
Time frame: 18 months
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with FSH-LH post-treatment.
variation of AMH directly involved with ovarian reserve in both groups
Time frame: 18 months
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with AMH values.
variation in recruitment of antral follicles in both groups
Time frame: 18 months
Both groups are compared after bio-stimulation and antioxidant therapy is performed to access any possible changes with the number of astral follicles available.
2 secondary outcomes
Number of good quality eggs obtained in both groups after IVF
Time frame: 18 months
Number and quality of fertilised eggs obtained in both groups after IVF
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Results publication: PubMed 26635884Bhartiya D, Parte S, Patel H, Sriraman K, Zaveri K, Hinduja I. Novel Action of FSH on Stem Cells in Adult Mammalian Ovary Induces Postnatal Oogenesis and Primordial Follicle Assembly. Stem Cells Int. 2016;2016:5096596. doi: 10.1155/2016/5096596. Epub 2015 Nov 9.
- Results publication: PubMed 15149546Telfer EE. Germline stem cells in the postnatal mammalian ovary: a phenomenon of prosimian primates and mice? Reprod Biol Endocrinol. 2004 May 18;2:24. doi: 10.1186/1477-7827-2-24. No abstract available.
- Results publication: PubMed 15014492Johnson J, Canning J, Kaneko T, Pru JK, Tilly JL. Germline stem cells and follicular renewal in the postnatal mammalian ovary. Nature. 2004 Mar 11;428(6979):145-50. doi: 10.1038/nature02316.
- Results publication: PubMed 26788065Pan Z, Sun M, Liang X, Li J, Zhou F, Zhong Z, Zheng Y. The Controversy, Challenges, and Potential Benefits of Putative Female Germline Stem Cells Research in Mammals. Stem Cells Int. 2016;2016:1728278. doi: 10.1155/2016/1728278. Epub 2015 Dec 15.
- Results publication: PubMed 26029346Ozakpinar OB, Maurer AM, Ozsavci D. Ovarian stem cells: From basic to clinical applications. World J Stem Cells. 2015 May 26;7(4):757-68. doi: 10.4252/wjsc.v7.i4.757.
- Results publication: PubMed 28264815Diamanti-Kandarakis E, Dattilo M, Macut D, Duntas L, Gonos ES, Goulis DG, Gantenbein CK, Kapetanou M, Koukkou E, Lambrinoudaki I, Michalaki M, Eftekhari-Nader S, Pasquali R, Peppa M, Tzanela M, Vassilatou E, Vryonidou A; COMBO ENDO TEAM: 2016. MECHANISMS IN ENDOCRINOLOGY: Aging and anti-aging: a Combo-Endocrinology overview. Eur J Endocrinol. 2017 Jun;176(6):R283-R308. doi: 10.1530/EJE-16-1061. Epub 2017 Mar 6.
- Results publication: PubMed 26829445Gat I, Blanco Mejia S, Balakier H, Librach CL, Claessens A, Ryan EA. The use of coenzyme Q10 and DHEA during IUI and IVF cycles in patients with decreased ovarian reserve. Gynecol Endocrinol. 2016 Jul;32(7):534-7. doi: 10.3109/09513590.2015.1137095. Epub 2016 Feb 1.
- Results publication: PubMed 27255570Ozcan P, Ficicioglu C, Kizilkale O, Yesiladali M, Tok OE, Ozkan F, Esrefoglu M. Can Coenzyme Q10 supplementation protect the ovarian reserve against oxidative damage? J Assist Reprod Genet. 2016 Sep;33(9):1223-30. doi: 10.1007/s10815-016-0751-z. Epub 2016 Jun 3.
- Individual participant dataSharing planned: Undecided. Still deciding if sharing information. It can be shared as long as it does not contain personal identification such as name, and contact details. We might share the rest of information to other scientist studying the same area of low-depleted ovarian reserve and bio-stimulation techniques.
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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.
Carmen Navarro, MD principal investigator
Medical staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood rich plasma platelets and Antioxidant therapy in people with Ovarian Reserve, run by Lucy Coleman at 1 site in Venezuela.
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 6 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: finished, as of the sponsor's last update on 8 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 1 site in Venezuela. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
variation of hormones FSH and LH directly involved with ovarian reserve (time frame: 18 months). 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 NCT03621683, which also lists 8 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 8 Aug 2018.