Ovarian FailureNCT04306185
Ovarian Fragmentation Study (Crespo Medical Team)
A study testing OVARIAN FRAGMENTATION in people with Ovarian Failure and Premature Ovarian Failure, run by Equipo Juana Crespo at 1 site in Spain.
Trial summary
This is a study designed to validate Kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. Our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Failure, Premature Ovarian Failure, IVF
- What is being tested?
- OVARIAN FRAGMENTATION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2020to 1 Mar 2021
- 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
- Abdominal surgery need for fertility cause.
- Bad embryo quality (>2 cycles with < 1 embryo A-B quality. With:
- Poor ovarian responders (previous ≤ 3 retrieved metaphase II oocytes) in a conventional cycle.
- Decreased ovarian reserve (antral follicle count (AFC) ≤ 5 or antiMullerian hormone (AMH) ≤ 0.5 ng/mL).
- C.Premature ovarian insufficiency according to:
- Patients < 40 years old.
Show all 9Show fewer
- At least 1 year of amenorrhea.
- Follitropin serum levels (FSH) >35 IU/ml in two serum samples separated by at least 1 month.
- Estradiol serum levels (E2) < 20 pg/mL.
Who cannot join
- Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma).
- Age over 45 years (EMC)
- Previous ovarian/pelvic surgery. Unilateral oophorectomy.
- Body Mass Index > 30
- Previous gonadotoxic treatment.
- Genito-urinary tract malformations.
- Inform consent unsigned.
Trial locations and contacts
1 site in 1 country.
About this study
This is a study designed to validate Kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. Our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.
- Conditions
- Ovarian Failure, Premature Ovarian Failure, IVF
- Being tested
- OVARIAN FRAGMENTATION
- Keywords
- ovarian fragmentation, Kawamura, ovarian rejuvenation
- 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.
OVARIAN FRAGMENTATIONProcedure or surgery
BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS
| Study group | Role | What they receive |
|---|---|---|
| OVARIAN FRAGMENTATION | Experimental | Ovarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve). Receives: Procedure: OVARIAN FRAGMENTATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
Embryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015).
Measured: 1 year
Secondary outcomes (5)
- Follicle growth rate before and after ovarian cortex fragmentation.
Number of antral Follicles in IVF treatment before ovarian fragmentation and after IVF following ovarian fragmentation.
Measured: 2 months.
- Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.
Measured: 2 months
- AntiMullerian hormone (AMH) serum levels before and two months after the procedure.
Measured: 2 months.
- Number of embryos before and after ovarian cortex fragmentation.
Measured: 2 months
- Clinical pregnancy rate following ovarian cortex fragmentation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ovarian FailureStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Equipo Juana Crespo
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306185
- Sponsor's protocol ID
- fibrotomia1
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Revelli A, Marchino G, Dolfin E, Molinari E, Delle Piane L, Salvagno F, Benedetto C. Live birth after orthotopic grafting of autologous cryopreserved ovarian tissue and spontaneous conception in Italy. Fertil Steril. 2013 Jan;99(1):227-230. doi: 10.1016/j.fertnstert.2012.09.029. Epub 2012 Oct 23.
PubMed 23102860Isachenko V, Isachenko E, Keck G, Dittrich R, Montag M, van der Ven H, Mallmann P, Muller A, Distler W, Beckmann MW, Rahimi G. First live birth in germany after re-transplantation of cryopreserved ovarian tissue: original device for initiation of ice formation. Clin Lab. 2012;58(9-10):933-8.
PubMed 23163109Baird DT, Webb R, Campbell BK, Harkness LM, Gosden RG. Long-term ovarian function in sheep after ovariectomy and transplantation of autografts stored at -196 C. Endocrinology. 1999 Jan;140(1):462-71. doi: 10.1210/endo.140.1.6453.
PubMed 9886858Donnez J, Dolmans MM, Demylle D, Jadoul P, Pirard C, Squifflet J, Martinez-Madrid B, Van Langendonckt A. Restoration of ovarian function after orthotopic (intraovarian and periovarian) transplantation of cryopreserved ovarian tissue in a woman treated by bone marrow transplantation for sickle cell anaemia: case report. Hum Reprod. 2006 Jan;21(1):183-8. doi: 10.1093/humrep/dei268. Epub 2005 Aug 25.
PubMed 16126712Callejo J, Salvador C, Gonzalez-Nunez S, Almeida L, Rodriguez L, Marques L, Valls A, Lailla JM. Live birth in a woman without ovaries after autograft of frozen-thawed ovarian tissue combined with growth factors. J Ovarian Res. 2013 May 7;6(1):33. doi: 10.1186/1757-2215-6-33.
PubMed 23647552Kawamura 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 27022685Donnez J, Jadoul P, Pirard C, Hutchings G, Demylle D, Squifflet J, Smitz J, Dolmans MM. Live birth after transplantation of frozen-thawed ovarian tissue after bilateral oophorectomy for benign disease. Fertil Steril. 2012 Sep;98(3):720-5. doi: 10.1016/j.fertnstert.2012.05.017. Epub 2012 Jun 13.
PubMed 22698640
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Fragmentation Study (Crespo Medical Team)
- ClinicalTrials.gov ID
- NCT04306185
- Acronym / sponsor ID
- fibrotomia1
- Conditions
- Ovarian Failure, Premature Ovarian Failure, IVF
- Keywords
- ovarian fragmentation, Kawamura, ovarian rejuvenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Equipo Juana CrespoResearch network
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 12 Mar 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.
This is a study designed to validate Kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. Our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OVARIAN FRAGMENTATION | Experimental | Procedure: OVARIAN FRAGMENTATIONOvarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Abdominal surgery need for fertility cause.
- Bad embryo quality (>2 cycles with < 1 embryo A-B quality. With:
- Poor ovarian responders (previous ≤ 3 retrieved metaphase II oocytes) in a conventional cycle.
- Decreased ovarian reserve (antral follicle count (AFC) ≤ 5 or antiMullerian hormone (AMH) ≤ 0.5 ng/mL).
- Patients < 40 years old.
Key exclusion criteria (7 listed)
- Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma).
- Age over 45 years (EMC)
- Previous ovarian/pelvic surgery. Unilateral oophorectomy.
- Body Mass Index > 30
- Previous gonadotoxic treatment.
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 FRAGMENTATIONBILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS | Procedure or surgery | OVARIAN FRAGMENTATION |
Primary outcome
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
Time frame: 1 year
Embryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015).
5 secondary outcomes
- Follicle growth rate before and after ovarian cortex fragmentation.
Time frame: 2 months.
- Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.
Time frame: 2 months
- AntiMullerian hormone (AMH) serum levels before and two months after the procedure.
Time frame: 2 months.
- Number of embryos before and after ovarian cortex fragmentation.
Time frame: 2 months
- Clinical pregnancy rate following ovarian cortex fragmentation.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Background: PubMed 23102860Revelli A, Marchino G, Dolfin E, Molinari E, Delle Piane L, Salvagno F, Benedetto C. Live birth after orthotopic grafting of autologous cryopreserved ovarian tissue and spontaneous conception in Italy. Fertil Steril. 2013 Jan;99(1):227-230. doi: 10.1016/j.fertnstert.2012.09.029. Epub 2012 Oct 23.
- Background: PubMed 23163109Isachenko V, Isachenko E, Keck G, Dittrich R, Montag M, van der Ven H, Mallmann P, Muller A, Distler W, Beckmann MW, Rahimi G. First live birth in germany after re-transplantation of cryopreserved ovarian tissue: original device for initiation of ice formation. Clin Lab. 2012;58(9-10):933-8.
- Background: PubMed 9886858Baird DT, Webb R, Campbell BK, Harkness LM, Gosden RG. Long-term ovarian function in sheep after ovariectomy and transplantation of autografts stored at -196 C. Endocrinology. 1999 Jan;140(1):462-71. doi: 10.1210/endo.140.1.6453.
- Background: PubMed 16126712Donnez J, Dolmans MM, Demylle D, Jadoul P, Pirard C, Squifflet J, Martinez-Madrid B, Van Langendonckt A. Restoration of ovarian function after orthotopic (intraovarian and periovarian) transplantation of cryopreserved ovarian tissue in a woman treated by bone marrow transplantation for sickle cell anaemia: case report. Hum Reprod. 2006 Jan;21(1):183-8. doi: 10.1093/humrep/dei268. Epub 2005 Aug 25.
- Background: PubMed 23647552Callejo J, Salvador C, Gonzalez-Nunez S, Almeida L, Rodriguez L, Marques L, Valls A, Lailla JM. Live birth in a woman without ovaries after autograft of frozen-thawed ovarian tissue combined with growth factors. J Ovarian Res. 2013 May 7;6(1):33. doi: 10.1186/1757-2215-6-33.
- Background: 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 22698640Donnez J, Jadoul P, Pirard C, Hutchings G, Demylle D, Squifflet J, Smitz J, Dolmans MM. Live birth after transplantation of frozen-thawed ovarian tissue after bilateral oophorectomy for benign disease. Fertil Steril. 2012 Sep;98(3):720-5. doi: 10.1016/j.fertnstert.2012.05.017. Epub 2012 Jun 13.
- 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. 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 OVARIAN FRAGMENTATION in people with Ovarian Failure and Premature Ovarian Failure, run by Equipo Juana Crespo 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 9 inclusion and 7 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 12 Mar 2020. 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 ANDER MORALES VICENTE (628802099, andermoralesvicente@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015) (time frame: 1 year). 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 NCT04306185, which also lists 7 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 12 Mar 2020.