IVF Clinical Trial of Two Different Treatment Protocols.

New Hope Fertility

Status: Completed

Conditions: Infertility

Treatments: Other: in vitro fertilization (IVF/ICSI)

Study type: Interventional

Funder types: Other

Identifiers

NCT00799929

NHFC

JZ-09-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 564 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Valid indication for IVF treatment
• First IVF attempt
• Female age between 18 and 38 years
• Male partner 18 years of age or older
• Both partners STD free
• Must be able to understand that they may NOT become pregnant

Exclusion criteria

• Not willing or able to sign the consent form
• Pre-existing medical condition preventing/interfering with IVF treatment
• Abnormal IVF screening tests, which includes Complete Blood Count, Varicella titer, Rubella titer, PAP smear, Syphilis, HIV 1&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea
• Abnormal pap smear
• Body Mass Index (BMI) falls below 18.5 or above 32.0
• Female participant with irregular menstrual cycles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

564 participants in 2 patient groups

ARM A - Mini IVF

Active Comparator group

Description:

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.

Treatment:

Other: in vitro fertilization (IVF/ICSI)

Arm B - Conventional IVF

Active Comparator group

Description:

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.

Treatment:

Other: in vitro fertilization (IVF/ICSI)