Infertility, FemaleNCT04390308
Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
An observational study of Infertility, Female and Premature Ovarian Failure, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
Premature ovarian failure (POI) is a loss of normal function before age 40, leading to infertility and hypoestrogenism. About 1% of women younger than 40 years old and 0.1% before 30 are affected. Most patients already had impaired or complete loss of fecundity when diagnosed. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female, Premature Ovarian Failure, IVF
- What is being tested?
- Ovarian puncture, Hormonal blood Test and Transvaginal ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 2 Jun 2021to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment
Who may be able to join
- Signed and dated informed consent
- Women 40 years of age and younger with documented primary ovarian insufficiency (12).
- Normal Karyotype
- BMI </= 35 kg/m2
- Oligo/amenorrhea for at least 4 months
- FSH > 25 IU/mL
Show all 11Show fewer
- AMH </= 0,1 ng/ml
- No evidence of follicles > 4mm
- Must have two ovaries of approximately equal volume.
- Willingness to undergo further fertility treatment, including IVF if there is evidence of response
- A transvaginal scan including Doppler for arteria ovarica will be performed previously to the surgical procedure.
Who cannot join
- Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality.
- Oncological diseases (specially, skeletal system and blood).
- Autoimmune diseases, for example, lupus erythematosus, etc.
- Previous treatments including radiotherapy or chemotherapy.
- Other conditions not suitable for surgical procedures and/or anesthesia.
- Anticoagulant or antiaggregant treatment.
Show all 9Show fewer
- Acute and chronic infectious diseases.
- Active substance abuse or dependence.
- Major Mental health disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 60202
Barbara Lawrenz, PhD, +97102 652 8000, jonalyn.edades@artfertilityclinics.com
jonalyn edades, RN, jonalyn.edades@artfertilityclinics.com
About this study
Official title: Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation? A Randomized Control Trial.
Premature ovarian failure (POI) is a loss of normal function before age 40, leading to infertility and hypoestrogenism. About 1% of women younger than 40 years old and 0.1% before 30 are affected. Most patients already had impaired or complete loss of fecundity when diagnosed. Hence, the treatment of POI is particularly tough. Currently, no optimal regimen exists to ameliorate ovarian function.
Read the detailed description
In women, the non-growing population of follicles that comprise the ovarian reserve is determined at birth and serves as the reservoir for future fertility. This reserve of dormant, primordial follicles and the mechanisms controlling their selective activation which constitute the committing step into folliculogenesis are essential for determining fertility outcomes in women.
While POI is sometimes called premature menopause, it is not identical with menopause. Women with POI may still have occasional irregular periods and may even occasionally achieve a pregnancy. Symptoms of POI include irregular menses or amenorrhea, infertility, hypoestrogenic symptoms and decreased libido. POI may be caused by chromosomal defects such as mosaic Turner's syndrome, exposure to toxins (chemotherapy or radiation), autoimmunity, genetic factors (FMR1) and other unknown factors.
Recently, new promising approaches have emerged for infertility treatment in patients with POI, which are based on arousing the still available primordial follicle pool. It is supposed that these techniques activate dormant primordial follicles using a combination of mechanical signaling and biochemical factors. The hypothesis that mild local ovarian injury, such as ovarian puncture, which is a usual procedure in an IVF center with minimal side effects, might exert a similar favorable effect in women with POI arouses our curiosity.
Different groups have published case series of ovarian procedures, injecting substances in the ovaries (A-PRP) or ovarian biopsies / scratch in infertile patients with low ovarian reserve (LOR) or/and patients with POF. However, those studies were underpowered, including not enough number of cases, with variable inclusion criteria and reporting results with very low scientific evidence. Furthermore, the mechanical effect of injecting the ovary should be taken into consideration during the evaluation of these patients, yet it might improve the ovarian function as well.
There are no previous randomized controlled trials considering a procedure as ovarian puncture, which is easier and accessible at any fertility center.
- Conditions
- Infertility, Female, Premature Ovarian Failure, IVF
- Being tested
- Ovarian puncture, Hormonal blood Test, Transvaginal ultrasound
- Medical subject headings
- Infertility, Female, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian punctureProcedure or surgery
Egg collection
Hormonal blood TestOther
AMH (ng/ml), FSH (IU/mL), E2(pg/mL), P4(ng/mL), LH (IU/mL)
Transvaginal ultrasoundDiagnostic test
Doppler of arteria ovarica. Resistance index
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The cortex of selected ovary will be punctured up to ten times. In the surgical report, the surgeon will state how many punctures have been done. Receives: Procedure: Ovarian puncture; Other: Hormonal blood Test; Diagnostic Test: Transvaginal ultrasound | |
| Control | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle growth above 4 mm
One or more follicles evaluated by transvaginal ultrasound. Defined by number of follicles growing, quantitative variable.
Measured: 1 day
Anti-Müllerian hormone evaluation after intervention.
Anti-Müllerian hormone evaluation after intervention.
Measured: 1 day
Follicle-stimulating hormone evaluation after intervention.
Follicle-stimulating hormone evaluation after intervention.
Measured: 1 day
Luteinizing hormone evaluation after intervention.
Luteinizing hormone evaluation after intervention.
Measured: 1 day
Estradiol hormone evaluation after intervention.
Estradiol hormone evaluation after intervention.
Measured: 1 day
Progesterone hormone evaluation after intervention.
Progesterone hormone evaluation after intervention.
Measured: 1 day
Spontaneous menstruation.
Spontaneous menstruation.
Measured: 1 day
Arteria ovarica doppler results.
Arteria ovarica doppler results. Resistance index.
Measured: 1 day
Secondary outcomes (5)
Number of follicles
Number of follicles
Measured: 1 day
Number of oocytes retrieved
Number of oocytes retrieved
Measured: 1 day
Fertilization rate
percentage of 2PN embryos per oocyte injected
Measured: 1 day
Blastulation rate
percentage of blastocysts per 2PN embryos
Measured: 1 day
Aneuploidy rate
percentage of aneuploid blastocysts per total blastocyst biopsied
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start2 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Melado, ART Fertility Clinics LLC
- Investigators
- Laura Melado, PhD, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390308
- Sponsor's protocol ID
- 2004-ABU-005-LM
- Status last verified
- Jan 2025
- First submitted
- 11 May 2020
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ford EA, Beckett EL, Roman SD, McLaughlin EA, Sutherland JM. Advances in human primordial follicle activation and premature ovarian insufficiency. Reproduction. 2020 Jan;159(1):R15-R29. doi: 10.1530/REP-19-0201.
PubMed 31376814Zhang X, Han T, Yan L, Jiao X, Qin Y, Chen ZJ. Resumption of Ovarian Function After Ovarian Biopsy/Scratch in Patients With Premature Ovarian Insufficiency. Reprod Sci. 2019 Feb;26(2):207-213. doi: 10.1177/1933719118818906. Epub 2018 Dec 12.
PubMed 30541396Kawamura K, Kawamura N, Hsueh AJ. Activation of dormant follicles: a new treatment for premature ovarian failure? Curr Opin Obstet Gynecol. 2016 Jun;28(3):217-22. doi: 10.1097/GCO.0000000000000268.
PubMed 27022685Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.
PubMed 21479340Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039.
PubMed 18480812Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
PubMed 20351977Sfakianoudis K, Simopoulou M, Nitsos N, Rapani A, Pantou A, Vaxevanoglou T, Kokkali G, Koutsilieris M, Pantos K. A Case Series on Platelet-Rich Plasma Revolutionary Management of Poor Responder Patients. Gynecol Obstet Invest. 2019;84(1):99-106. doi: 10.1159/000491697. Epub 2018 Aug 22.
PubMed 30134239Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.
PubMed 29486615Sills ES, Li X, Rickers NS, Wood SH, Palermo GD. Metabolic and neurobehavioral response following intraovarian administration of autologous activated platelet rich plasma: First qualitative data. Neuro Endocrinol Lett. 2019 Jan;39(6):427-433.
PubMed 30796792Sills ES, Rickers NS, Svid CS, Rickers JM, Wood SH. Normalized Ploidy Following 20 Consecutive Blastocysts with Chromosomal Error: Healthy 46, XY Pregnancy with IVF after Intraovarian Injection of Autologous Enriched Platelet-derived Growth Factors. Int J Mol Cell Med. 2019 Winter;8(1):84-90. doi: 10.22088/IJMCM.BUMS.8.1.84. Epub 2019 May 15.
PubMed 32195207European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.
PubMed 27008889
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation? A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04390308
- Acronym / sponsor ID
- 2004-ABU-005-LM
- Conditions
- Infertility, Female, Premature Ovarian Failure, IVF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 May 2020 (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.
Premature ovarian failure (POI) is a loss of normal function before age 40, leading to infertility and hypoestrogenism. About 1% of women younger than 40 years old and 0.1% before 30 are affected. Most patients already had impaired or complete loss of fecundity when diagnosed. Hence, the treatment of POI is particularly tough. Currently, no optimal regimen exists to ameliorate ovarian function.
Detailed description
In women, the non-growing population of follicles that comprise the ovarian reserve is determined at birth and serves as the reservoir for future fertility. This reserve of dormant, primordial follicles and the mechanisms controlling their selective activation which constitute the committing step into folliculogenesis are essential for determining fertility outcomes in women.
While POI is sometimes called premature menopause, it is not identical with menopause. Women with POI may still have occasional irregular periods and may even occasionally achieve a pregnancy. Symptoms of POI include irregular menses or amenorrhea, infertility, hypoestrogenic symptoms and decreased libido. POI may be caused by chromosomal defects such as mosaic Turner's syndrome, exposure to toxins (chemotherapy or radiation), autoimmunity, genetic factors (FMR1) and other unknown factors.
Recently, new promising approaches have emerged for infertility treatment in patients with POI, which are based on arousing the still available primordial follicle pool. It is supposed that these techniques activate dormant primordial follicles using a combination of mechanical signaling and biochemical factors. The hypothesis that mild local ovarian injury, such as ovarian puncture, which is a usual procedure in an IVF center with minimal side effects, might exert a similar favorable effect in women with POI arouses our curiosity.
Different groups have published case series of ovarian procedures, injecting substances in the ovaries (A-PRP) or ovarian biopsies / scratch in infertile patients with low ovarian reserve (LOR) or/and patients with POF. However, those studies were underpowered, including not enough number of cases, with variable inclusion criteria and reporting results with very low scientific evidence. Furthermore, the mechanical effect of injecting the ovary should be taken into consideration during the evaluation of these patients, yet it might improve the ovarian function as well.
There are no previous randomized controlled trials considering a procedure as ovarian puncture, which is easier and accessible at any fertility center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Procedure: Ovarian puncture, Other: Hormonal blood Test, Diagnostic Test: Transvaginal ultrasoundThe cortex of selected ovary will be punctured up to ten times. In the surgical report, the surgeon will state how many punctures have been done. |
| Control | – | –No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment
Key inclusion criteria (11 listed)
- Signed and dated informed consent
- Women 40 years of age and younger with documented primary ovarian insufficiency (12).
- Normal Karyotype
- BMI </= 35 kg/m2
- Oligo/amenorrhea for at least 4 months
Key exclusion criteria (9 listed)
- Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality.
- Oncological diseases (specially, skeletal system and blood).
- Autoimmune diseases, for example, lupus erythematosus, etc.
- Previous treatments including radiotherapy or chemotherapy.
- Other conditions not suitable for surgical procedures and/or anesthesia.
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 |
|---|---|---|
| Ovarian punctureEgg collection | Procedure or surgery | Intervention |
| Hormonal blood TestAMH (ng/ml), FSH (IU/mL), E2(pg/mL), P4(ng/mL), LH (IU/mL) | Other | Intervention |
| Transvaginal ultrasoundDoppler of arteria ovarica. Resistance index | Diagnostic test | Intervention |
Primary outcome
Follicle growth above 4 mm
Time frame: 1 day
One or more follicles evaluated by transvaginal ultrasound. Defined by number of follicles growing, quantitative variable.
Anti-Müllerian hormone evaluation after intervention.
Time frame: 1 day
Anti-Müllerian hormone evaluation after intervention.
Follicle-stimulating hormone evaluation after intervention.
Time frame: 1 day
Follicle-stimulating hormone evaluation after intervention.
Luteinizing hormone evaluation after intervention.
Time frame: 1 day
Luteinizing hormone evaluation after intervention.
Estradiol hormone evaluation after intervention.
Time frame: 1 day
Estradiol hormone evaluation after intervention.
Progesterone hormone evaluation after intervention.
Time frame: 1 day
Progesterone hormone evaluation after intervention.
Spontaneous menstruation.
Time frame: 1 day
Spontaneous menstruation.
Arteria ovarica doppler results.
Time frame: 1 day
Arteria ovarica doppler results. Resistance index.
5 secondary outcomes
Number of follicles
Time frame: 1 day
Number of oocytes retrieved
Time frame: 1 day
Fertilization rate
Time frame: 1 day
Blastulation rate
Time frame: 1 day
Aneuploidy rate
Time frame: 1 day
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 19 Feb 2025.
- Results publication: PubMed 31376814Ford EA, Beckett EL, Roman SD, McLaughlin EA, Sutherland JM. Advances in human primordial follicle activation and premature ovarian insufficiency. Reproduction. 2020 Jan;159(1):R15-R29. doi: 10.1530/REP-19-0201.
- Results publication: PubMed 30541396Zhang X, Han T, Yan L, Jiao X, Qin Y, Chen ZJ. Resumption of Ovarian Function After Ovarian Biopsy/Scratch in Patients With Premature Ovarian Insufficiency. Reprod Sci. 2019 Feb;26(2):207-213. doi: 10.1177/1933719118818906. Epub 2018 Dec 12.
- Results publication: PubMed 27022685Kawamura K, Kawamura N, Hsueh AJ. Activation of dormant follicles: a new treatment for premature ovarian failure? Curr Opin Obstet Gynecol. 2016 Jun;28(3):217-22. doi: 10.1097/GCO.0000000000000268.
- Results publication: PubMed 21479340Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.
- Results publication: PubMed 18480812Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039.
- Results publication: PubMed 20351977Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.
- Results publication: PubMed 30134239Sfakianoudis K, Simopoulou M, Nitsos N, Rapani A, Pantou A, Vaxevanoglou T, Kokkali G, Koutsilieris M, Pantos K. A Case Series on Platelet-Rich Plasma Revolutionary Management of Poor Responder Patients. Gynecol Obstet Invest. 2019;84(1):99-106. doi: 10.1159/000491697. Epub 2018 Aug 22.
- Results publication: PubMed 29486615Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.
- Results publication: PubMed 30796792Sills ES, Li X, Rickers NS, Wood SH, Palermo GD. Metabolic and neurobehavioral response following intraovarian administration of autologous activated platelet rich plasma: First qualitative data. Neuro Endocrinol Lett. 2019 Jan;39(6):427-433.
- Results publication: PubMed 32195207Sills ES, Rickers NS, Svid CS, Rickers JM, Wood SH. Normalized Ploidy Following 20 Consecutive Blastocysts with Chromosomal Error: Healthy 46, XY Pregnancy with IVF after Intraovarian Injection of Autologous Enriched Platelet-derived Growth Factors. Int J Mol Cell Med. 2019 Winter;8(1):84-90. doi: 10.22088/IJMCM.BUMS.8.1.84. Epub 2019 May 15.
- Results publication: PubMed 27008889European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.
- Ovarian rejuvenation and folliculogenesis reactivation in peri-menopausal women after autologous platelet-rich plasma treatmentLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Laura Melado, PhD principal investigator
ART Fertility Clinics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Premature Ovarian Failure, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. 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 United Arab Emirates. 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?
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 barbara Lawrenz, PhD (+97126528000 ext. 1108, jonalyn.edades@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicle growth above 4 mm (time frame: 1 day). The study lists 8 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 NCT04390308, which also lists 11 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 19 Feb 2025.