In Vitro Maturation (IVM) of Human Oocytes

Polycystic Ovarian Syndrome (PCOS) Clinical Trial

— IVM  

Official title:

In Vitro Maturation (IVM) of Human Oocytes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01843569
• Other study ID #: 12-364A
• Status: Withdrawn
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Hyper Stimulation Syndrome (OHSS)
• Ovarian Hyperstimulation Syndrome
• Patients Sensitive to Exogenous Gonadotropins
• Polycystic Ovarian Syndrome (PCOS)
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Biological:
• In Vitro maturation

Locations

Country	Name	City	State
United States	The Center for Human Reproduction	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Chian RC, Buckett WM, Tan SL. In-vitro maturation of human oocytes. Reprod Biomed Online. 2004 Feb;8(2):148-66. Review. — View Citation

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. — View 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. Epub 2004 Nov 4. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	Establishment of a successful pregnancy	1 month
Primary	Implantation	fetal hearts per embryo replaced	1 month
Primary	live birth rates		9 months
Secondary	Multiple pregnancy and miscarriage rates		9 months
Secondary	Neonatal outcomes		9 months
Secondary	Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])		2 weeks
Secondary	Number and size distribution of follicles (=11 mm, =15 mm, and =17 mm) as documented by ultrasonography during treatment		2 weeks
Secondary	Number and quality of oocytes retrieved		1 day
Secondary	Oocyte maturation rate		1 week
Secondary	Number of fertilized oocytes		2 days
Secondary	Fertilization rate		1 day
Secondary	Number and quality of embryos generated		1 week
Secondary	Endometrial thickness		2 weeks