IVF Clinical Trial of Two Different Treatment Protocols.

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: in vitro fertilization (IVF/ICSI)

• Registration Number: NCT00799929
• Lead Sponsor: New Hope Fertility Center

Brief Summary

The purpose of this study is to compare two different in vitro fertilization (IVF) treatments: conventional IVF protocol and minimal stimulation IVF protocol, in terms of success rates, stress of treatment, drug-related side effects, multiple pregnancies and cost of treatment.

Detailed Description

A random population of 564 sub-fertile women or couples with a female between ages of 18 and 38 years and a desire to undergo their first IVF cycle will be included in this outpatient clinical trial. The participation in this study will be approximately six months with a total of 20 to 25 visits. After successful completion of the pre-screening tests participants are randomized into one of the two arms of the study: Arm A - mini IVF protocol, and Arm B - conventional IVF protocol.

Study Timeline

• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-28
• Study Start: 2008-12
• Study First Posted: 2008-12-01
• Primary Completion: 2014-05
• Study Completion: 2014-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 564

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B - Conventional IVF	in vitro fertilization (IVF/ICSI)	The standard IVF method entails pre-treatment with a GnRH analog injections in the midluteal phase. Controlled ovarian hyperstimulation is achieved with injections of gonadotropin (150IU-300IU/day). Ovulation is induced by hCG injection and retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. If this occurs on day 5, then fresh SET/DET (single embryo transfer/double embryo transfer) is performed. Remaining blastocysts are cryopreserved and transferred in subsequent natural cycles/HRT (hormone replacement therapy) that does not involve ovarian stimulation.
ARM A - Mini IVF	in vitro fertilization (IVF/ICSI)	The Mini IVF method entails pre-treatment with oral contraceptive pills. Ovarian stimulation is achieved using an oral anti-estrogen in conjunction with injections of gonadotropin (225IU-600IU per cycle), with initial dose of 75IU-150IU per injection. Ovulation is induced by a GnRH (gonadotropin-releasing hormone) agonist nasal spray/hCG (human chorionic gonadotropin) injection. Retrieved oocytes following in vitro fertilization (IVF/ICSI) are cultured to the blastocyst stage. Blastocyst stage embryos are vitrified using the CryoTop method. No fresh embryo transfer is conducted. Subsequently, SET of a thawed blastocyst is performed in a natural cycle/HRT that does not involve ovarian stimulation. SETs are conducted until pregnancy is achieved or all vitrified blastocysts have been used.

Primary Outcome Measures

Name	Time	Method
Primary outcome parameter: Live birth	4 Years

Secondary Outcome Measures

Name	Time	Method
Secondary outcome parameters: Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Multiple pregnancy rate, Miscarriage rate, Fertilization rate, Number of oocytes, Number of embryos	4 Years

Trial Locations

Locations (1)

New Hope Fertility Center; 🇺🇸 New York, New York, United States