In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization

Infertility Clinical Trial

— IVM vs IVF  

Official title:

Clinical Research Study on in Vitro Maturation With IVF Compared to Mild Stimulation IVF

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00867763
• Other study ID #: 2939
• Status: Suspended
• Phase: N/A
• First received: March 23, 2009
• Last updated: August 10, 2010
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: March 2009
• Source: Batzofin Fertility Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.

Description:

Low cost environment is utilized, but fees are charged.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1440
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 41 Years

Eligibility

Inclusion Criteria:

• Under age 42 female, normal uterine cavity, BMI 18-34kg/m2,

Exclusion Criteria:

• Donor eggs, donor sperm, myoma over 5 cm

• Current hydrosalpinx, abnormal uterine cavity.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• In vitro maturation and in vitro fertilization
No gonadotropin, eggs harvested early
• Low doses of gonadotropin stimulation.
Gonadotropin followed by conventional IVF

Locations

Country	Name	City	State
United States	Batzofin Fertilty Services	New York	New York
United States	BFS	NY	New York

Sponsors (1)

Lead Sponsor	Collaborator
Batzofin Fertility Services

Country where clinical trial is conducted

United States, 

References & Publications (2)

Son WY, Chung JT, Demirtas E, Holzer H, Sylvestre C, Buckett W, Chian RC, Tan SL. Comparison of in-vitro maturation cycles with and without in-vivo matured oocytes retrieved. Reprod Biomed Online. 2008 Jul;17(1):59-67. — View Citation

Son WY, Chung JT, Herrero B, Dean N, Demirtas E, Holzer H, Elizur S, Chian RC, Tan SL. Selection of the optimal day for oocyte retrieval based on the diameter of the dominant follicle in hCG-primed in vitro maturation cycles. Hum Reprod. 2008 Dec;23(12):2680-5. doi: 10.1093/humrep/den332. Epub 2008 Sep 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost effectiveness		two years	Yes
Secondary	Ongoing pregnancy rates per cycle		3 months	No