In Vitro Maturation (IVM) of Human Oocytes
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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Elimination of the need for gonadotropin ovarian stimulation
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Elimination of risk of developing OHSS
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Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring
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Reduced cost of treatment
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Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IVM All patients registered in this study will undergo natural cycle IVF with In Vitro maturation (IVM) performed on all immature retrieved oocytes. |
Biological: In Vitro maturation
|
Outcome Measures
Primary Outcome Measures
- Pregnancy [1 month]
Establishment of a successful pregnancy
- Implantation [1 month]
fetal hearts per embryo replaced
- live birth rates [9 months]
Secondary Outcome Measures
- Multiple pregnancy and miscarriage rates [9 months]
- Neonatal outcomes [9 months]
- Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH]) [2 weeks]
- Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment [2 weeks]
- Number and quality of oocytes retrieved [1 day]
- Oocyte maturation rate [1 week]
- Number of fertilized oocytes [2 days]
- Fertilization rate [1 day]
- Number and quality of embryos generated [1 week]
- Endometrial thickness [2 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Each subject must be female.
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Each subject must have an indication for COH and IVF or ICSI.
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Each subject must be willing and able to provide written informed consent for the trial.
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Each subject must be ≤42 years of age at the time of signing informed consent.
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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:
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Subject with premature ovarian failure.
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Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction.
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Subject with malformation or absence of uterus.
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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).
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Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Center for Human Reproduction | Manhasset | New York | United States | 11030 |
Sponsors and Collaborators
- Northwell Health
Investigators
- Principal Investigator: Avner Hershlag, MD, NSLIJ
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Chian RC, Buckett WM, Tan SL. In-vitro maturation of human oocytes. Reprod Biomed Online. 2004 Feb;8(2):148-66. Review.
- Jurema MW, Nogueira D. In vitro maturation of human oocytes for assisted reproduction. Fertil Steril. 2006 Nov;86(5):1277-91. Epub 2006 Sep 25. Review.
- 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. Epub 2004 Nov 4.
- 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.
- 12-364A