In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization - Full Text View

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

This study is currently recruiting participants.

Verified by Batzofin Fertility Services, March 2009

First Received: March 23, 2009 No Changes Posted

Sponsored by:	Batzofin Fertility Services
Information provided by:	Batzofin Fertility Services
ClinicalTrials.gov Identifier:	NCT00867763

Purpose

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.

Condition	Intervention
Infertility	Procedure: In vitro maturation and in vitro fertilization Procedure: Low doses of gonadotropin stimulation.

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Clinical Research Study on in Vitro Maturation With IVF Compared to Mild Stimulation IVF

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by Batzofin Fertility Services:

Primary Outcome Measures:

Cost effectiveness [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Ongoing pregnancy rates per cycle [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1440
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IVM: Experimental Early egg retrieval, in vitro maturation, then IVF	Procedure: In vitro maturation and in vitro fertilization No gonadotropin, eggs harvested early
Mild IVF: Active Comparator Mild gonadotropin and conventional IVF	Procedure: Low doses of gonadotropin stimulation. Gonadotropin followed by conventional IVF

Detailed Description:

Low cost environment is utilized, but fees are charged.

Eligibility

Ages Eligible for Study:	21 Years to 41 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867763

Contacts

Contact: Joe B Massey, MD	212-679-2289	jmassey@batzofinfertility.com
Contact: Stefany Larsen, RN	212-679-2289

Locations

United States, New York
Batzofin Fertilty Services	Recruiting
New York, New York, United States, 10016
Contact: Joe B Massey, MD 212-679-2289 jmassey@batzofinfertilty.com
Contact: Stefany Larsen, RN 212-679-2289 slarsen@batzofinfertility.com
Sub-Investigator: Joel Batzofin, MD

Sponsors and Collaborators

Batzofin Fertility Services

Investigators

Principal Investigator:

Joe B Massey, MD

Batzofin Fertility Services

More Information

Additional Information:

investigator site with expanded information under IVM study listing This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2008 Sep 4.

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.

Responsible Party:	Batzofin Fertility Services ( Joe B. Massey MD )
Study ID Numbers:	2939
Study First Received:	March 23, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00867763 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Batzofin Fertility Services:

Polycystic ovaries,
Tubal occlusion
Unexplained infertility
Low ovarian reserve
Male factor infertility

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Polycystic Ovarian Syndrome

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on August 25, 2009