Polycystic Ovary SyndromeIVMprtNCT04149496
IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer
A study testing in vitro maturation of oocytes in people with Polycystic Ovary Syndrome, run by Bruce Rose, MD at 1 site in United States.
Trial summary
A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- in vitro maturation of oocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 31 Dec 2023
- Phase
- Interventional
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCO pattern with > 25 antral follicles
- AMH > 3.5
Who cannot join
- BMI > 35
- body morphology making transvaginal retrieval difficult or impossible
- complicating medical condition making pregnancy or IVF relatively contra-indicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown Fertility
Jacksonville, Florida, 32256
Julius Varzoni, BS, 904-260-0352, jvarzoni@brownfertility.com
Meaghan German, RN, 904-260-0352, mgerman@brownfertility.com
About this study
Official title: A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle
A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.
Read the detailed description
All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- in vitro maturation of oocytes
- Keywords
- IVM, in vitro maturation, polycystic ovarian syndrome, PCOS, Steiner-Tan needle, oocyte maturation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro maturation of oocytesCombination product
Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization
| Study group | Role | What they receive |
|---|---|---|
| All | Experimental | Patients requiring IVF treatment with PCOS or a PCO pattern in their ovaries who wish to undertake IVM (as a variant of their IVF procedure) Receives: Combination Product: in vitro maturation of oocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treated patients having a clinical pregnancy
ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy
Measured: 12 weeks post transfer
Percentage of treated patients having an ongoing pregnancy
pregnancy with cardiac activity (by history or observations) after 12 weeks
Measured: 10 months post transfer
Secondary outcomes (5)
Percentage of retrieved oocytes which matured per patient
proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval
Measured: 2 days post retrieval
Percentage of retrieved oocytes which fertilized per patient
proportion of mature oocytes which display pronuclei
Measured: 4 days post retrieval
Percentage of fertilized oocytes which divided
proportion of fertilized oocytes which become 2 or more cells
Measured: 6 days post retrieval
Percentage of fertilized oocytes which became blastocysts per patient
proportion of fertilized oocytes which form a fluid filled cavity
Measured: 8 days post retrieval
Percentage of patients who have a biochemical pregnancy after therir first transfer
proportion of patients with an hCG level greater than 5 measured post first transfer
Measured: 28 days post transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start10 May 2019
- Primary completion1 Apr 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Model description
- Prospective series
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruce Rose, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruce Rose, MD, Brown Fertility
- Investigators
- Bruce I Rose, MD, PhD, Principal investigator, Brown Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149496
- Sponsor's protocol ID
- 18-49
- Acronym
- IVMprt
- Status last verified
- Oct 2019
- First submitted
- 9 Jul 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5.
PubMed 25374658Rose BI: The case for more active management of endometrial development in IVM: Decreasing the miscarriage rate and increasing the clinical pregnancy rate. Journal of Reproductive Endocrinology and Infertility, 14: 1-6, 2016
Rose BI, Laky D. A comparison of the Cook single lumen immature ovum IVM needle to the Steiner-Tan pseudo double lumen flushing needle for oocyte retrieval for IVM. J Assist Reprod Genet. 2013 Jun;30(6):855-60. doi: 10.1007/s10815-013-0006-1. Epub 2013 May 5.
PubMed 23644950
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle
- ClinicalTrials.gov ID
- NCT04149496
- Acronym / sponsor ID
- IVMprt / 18-49
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- IVM, in vitro maturation, polycystic ovarian syndrome, PCOS, Steiner-Tan needle, oocyte maturation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bruce Rose, MDUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Nov 2019 (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.
A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.
Detailed description
All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective series
| Arm | Type | Receives |
|---|---|---|
| All | Experimental | Combination Product: in vitro maturation of oocytesPatients requiring IVF treatment with PCOS or a PCO pattern in their ovaries who wish to undertake IVM (as a variant of their IVF procedure) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PCO pattern with > 25 antral follicles
- AMH > 3.5
Key exclusion criteria (3 listed)
- BMI > 35
- body morphology making transvaginal retrieval difficult or impossible
- complicating medical condition making pregnancy or IVF relatively contra-indicated
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 maturation of oocytesImmature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization | Combination product | All |
Primary outcome
Percentage of treated patients having a clinical pregnancy
Time frame: 12 weeks post transfer
ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy
Percentage of treated patients having an ongoing pregnancy
Time frame: 10 months post transfer
pregnancy with cardiac activity (by history or observations) after 12 weeks
5 secondary outcomes
Percentage of retrieved oocytes which matured per patient
Time frame: 2 days post retrieval
Percentage of retrieved oocytes which fertilized per patient
Time frame: 4 days post retrieval
Percentage of fertilized oocytes which divided
Time frame: 6 days post retrieval
Percentage of fertilized oocytes which became blastocysts per patient
Time frame: 8 days post retrieval
Percentage of patients who have a biochemical pregnancy after therir first transfer
Time frame: 28 days post transfer
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 4 Nov 2019.
- Background: PubMed 25374658Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5.
- BackgroundRose BI: The case for more active management of endometrial development in IVM: Decreasing the miscarriage rate and increasing the clinical pregnancy rate. Journal of Reproductive Endocrinology and Infertility, 14: 1-6, 2016
- Background: PubMed 23644950Rose BI, Laky D. A comparison of the Cook single lumen immature ovum IVM needle to the Steiner-Tan pseudo double lumen flushing needle for oocyte retrieval for IVM. J Assist Reprod Genet. 2013 Jun;30(6):855-60. doi: 10.1007/s10815-013-0006-1. Epub 2013 May 5.
- Individual participant dataSharing planned: No
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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.
Bruce I Rose, MD, PhD principal investigator
Brown Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in vitro maturation of oocytes in people with Polycystic Ovary Syndrome, run by Bruce Rose, MD at 1 site 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 3 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 4 Nov 2019. 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 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?
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 Bruce I Rose, MD, PhD (904-260-0352, brose@brownfertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of treated patients having a clinical pregnancy (time frame: 12 weeks post transfer). The study lists 2 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 NCT04149496, which also lists 3 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 4 Nov 2019.