Clinical trial NCT01843569: In Vitro Maturation (IVM) of Human Oocytes
Official title: In Vitro Maturation (IVM) of Human Oocytes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Polycystic Ovarian Syndrome (PCOS)
Patients Sensitive to Exogenous Gonadotropins
Ovarian Hyper Stimulation Syndrome (OHSS)
Keywords: In Vitro Maturation
IVM
Natural cycle IVF
PCOS
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

1. Each subject must be female.
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:

1. Subject with premature ovarian failure.
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.

Primary outcomes:
measure: Pregnancy
timeFrame: 1 month
measure: Implantation
timeFrame: 1 month
measure: live birth rates
timeFrame: 9 months
Secondary outcomes:
measure: Multiple pregnancy and miscarriage rates
timeFrame: 9 months
measure: Neonatal outcomes
timeFrame: 9 months
measure: Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])
timeFrame: 2 weeks
measure: Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment
timeFrame: 2 weeks
measure: Number and quality of oocytes retrieved
timeFrame: 1 day
measure: Oocyte maturation rate
timeFrame: 1 week
measure: Number of fertilized oocytes
timeFrame: 2 days
measure: Fertilization rate
timeFrame: 1 day
measure: Number and quality of embryos generated
timeFrame: 1 week
measure: Endometrial thickness
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Center for Human Reproduction
state: New York
Study officials:
affiliation: NSLIJ
name: Avner Hershlag, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.