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Polycystic Ovarian Syndrome (PCOS)IVMNCT01843569

In Vitro Maturation (IVM) of Human Oocytes

A study testing In Vitro maturation in people with Polycystic Ovarian Syndrome (PCOS) and Patients Sensitive to Exogenous Gonadotropins, run by Northwell Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk of ovarian hyperstimulation syndrome. Read more about this study

Who is it for?
Ages 25 to 42 years, women onlyHealthy volunteers can take part
What is being tested?
In Vitro maturation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2015to Dec 2020
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 25 to 42 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Each subject must be female.
  • Each subject must have an indication for COH and IVF or ICSI.
  • Each subject must be willing and able to provide written informed consent for the trial.
  • Each subject must be ≤42 years of age at the time of signing informed consent.
  • Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to signing informed consent must be available.

Who cannot join

  • Subject with premature ovarian failure.
  • Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction.
  • Subject with malformation or absence of uterus.
  • Subject tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).
  • Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Center for Human Reproduction

    Manhasset, New York, 11030

Other trials in United States

About this study

We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk of ovarian hyperstimulation syndrome.

Read the detailed description

Natural IVF/IVM may be an attractive treatment alternative to conventional controlled ovarian hyperstimulation (COH)/IVF treatment for infertile women in particular for a select group.

Natural IVF/IVM offers several advantages over conventional COH protocols for IVF including:

  1. Elimination of the need for gonadotropin ovarian stimulation
  2. Elimination of risk of developing OHSS
  3. Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring
  4. Reduced cost of treatment
  5. Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings
  6. Eliminates concerns about the potential risk of malignancy that may be associated with multiple cycles of ovarian stimulation in a predisposed population.

This pilot study will be conducted to assess the clinical efficacy of natural IVF/IVM

Being tested
In Vitro maturation
Keywords
In Vitro Maturation, IVM, Natural cycle IVF, PCOS
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 maturationBiological

Study groups in NCT01843569
Study groupRoleWhat they receive
IVMExperimentalAll patients registered in this study will undergo natural cycle IVF with In Vitro maturation (IVM) performed on all immature retrieved oocytes.
Receives: Biological: In Vitro maturation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pregnancy

    Establishment of a successful pregnancy

    Measured: 1 month

  2. Implantation

    fetal hearts per embryo replaced

    Measured: 1 month

  3. live birth rates

    Measured: 9 months

Secondary outcomes (10)

  1. Multiple pregnancy and miscarriage rates

    Measured: 9 months

  2. Neonatal outcomes

    Measured: 9 months

  3. Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])

    Measured: 2 weeks

  4. Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment

    Measured: 2 weeks

  5. Number and quality of oocytes retrieved

    Measured: 1 day

  6. Oocyte maturation rate

    Measured: 1 week

  7. Number of fertilized oocytes

    Measured: 2 days

  8. Fertilization rate

    Measured: 1 day

  9. Number and quality of embryos generated

    Measured: 1 week

  10. Endometrial thickness

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: Institutional approval of study has expired.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843569
Sponsor's protocol ID
12-364A
Acronym
IVM
Status last verified
Nov 2020
First submitted
26 Apr 2013
Last updated
16 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Practice Committee of the American Society for Reproductive Medicine (ASRM). Committee opinion: In Vitro Maturation. Fertil & Steril. Ready for member review 2/21/12. Not yet in print.

  • Le Du A, Kadoch IJ, Bourcigaux N, Doumerc S, Bourrier MC, Chevalier N, Fanchin R, Chian RC, Tachdjian G, Frydman R, Frydman N. In vitro oocyte maturation for the treatment of infertility associated with polycystic ovarian syndrome: the French experience. Hum Reprod. 2005 Feb;20(2):420-4. doi: 10.1093/humrep/deh603. Epub 2004 Nov 4.

    PubMed 15528263

  • Chian RC, Buckett WM, Tan SL. In-vitro maturation of human oocytes. Reprod Biomed Online. 2004 Feb;8(2):148-66. doi: 10.1016/s1472-6483(10)60511-1.

    PubMed 14989791

  • Jurema MW, Nogueira D. In vitro maturation of human oocytes for assisted reproduction. Fertil Steril. 2006 Nov;86(5):1277-91. doi: 10.1016/j.fertnstert.2006.02.126. Epub 2006 Sep 25.

    PubMed 16996508

  • Buckett WM, Chian RC, Holzer H, Dean N, Usher R, Tan SL. Obstetric outcomes and congenital abnormalities after in vitro maturation, in vitro fertilization, and intracytoplasmic sperm injection. Obstet Gynecol. 2007 Oct;110(4):885-91. doi: 10.1097/01.AOG.0000284627.38540.80.

    PubMed 17906024

Questions about this trial

What is this clinical trial studying?

A study testing In Vitro maturation in people with Polycystic Ovarian Syndrome (PCOS) and Patients Sensitive to Exogenous Gonadotropins, run by Northwell Health 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Nov 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Pregnancy (time frame: 1 month). 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 NCT01843569, which also lists 5 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 16 Nov 2020.

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