Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-01-31
2020-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IVM
All patients registered in this study will undergo natural cycle IVF with In Vitro maturation (IVM) performed on all immature retrieved oocytes.
In Vitro maturation
Interventions
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In Vitro maturation
Eligibility Criteria
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Inclusion Criteria
2. Each subject must have an indication for COH and IVF or ICSI.
3. Each subject must be willing and able to provide written informed consent for the trial.
4. Each subject must be ≤42 years of age at the time of signing informed consent.
5. 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.
Exclusion Criteria
2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction.
3. Subject with malformation or absence of uterus.
4. 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).
5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone.
25 Years
42 Years
FEMALE
Yes
Sponsors
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Northwell Health
OTHER
Responsible Party
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Principal Investigators
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Avner Hershlag, MD
Role: PRINCIPAL_INVESTIGATOR
NSLIJ
Locations
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The Center for Human Reproduction
Manhasset, New York, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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12-364A
Identifier Type: -
Identifier Source: org_study_id