IVF Clinical Trial of Two Different Treatment Protocols.
This study is currently recruiting participants.
Verified October 2012 by New Hope Fertility Center
Sponsor:
New Hope Fertility Center
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
New York Downtown Hospital
Information provided by (Responsible Party):
New Hope Fertility Center
ClinicalTrials.gov Identifier:
NCT00799929
First received: November 26, 2008
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infertility |
Other: in vitro fertilization (IVF/ICSI) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficiency and Patient Satisfaction of Two Different IVF Protocols. |
Resource links provided by NLM:
Further study details as provided by New Hope Fertility Center:
Primary Outcome Measures:
- Primary outcome parameter: Live birth [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary outcome parameters: Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Multiple pregnancy rate, Miscarriage rate, Fertilization rate, Number of oocytes, Number of embryos [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 564 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ARM A - Mini IVF
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.
|
Other: in vitro fertilization (IVF/ICSI) |
|
Active Comparator: Arm B - Conventional IVF
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.
|
Other: in vitro fertilization (IVF/ICSI) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 38 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799929
Contacts
| Contact: Maciej W. Feret, MS | 212-400-9636 | info@ivfclinicaltrial.com |
| Contact: Henriette Julien, MD | 212-400-9626 | info@ivfclinicaltrial.com |
Locations
| United States, New York | |
| New Hope Fertility Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Maciej Feret, MS 212-400-9636 info@ivfclinicaltrial.com | |
| Principal Investigator: John J. Zhang, MD, MSc, PhD | |
| Sub-Investigator: Fulco van der Veen, MD, PhD | |
| Sub-Investigator: Sjoerd Repping, PhD | |
| Sub-Investigator: Madelon van Wely, PhD | |
| Sub-Investigator: Lyndon Chang, MD | |
| Sub-Investigator: Samuel Wong, MD | |
| Sub-Investigator: Mingxue Yang, MD | |
| Sub-Investigator: Janelle Luk, MD | |
| Sub-Investigator: Sherman Silber, MD | |
Sponsors and Collaborators
New Hope Fertility Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
New York Downtown Hospital
Investigators
| Principal Investigator: | John J Zhang, MD, MSc, PhD | New Hope Fertility Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | New Hope Fertility Center |
| ClinicalTrials.gov Identifier: | NCT00799929 History of Changes |
| Other Study ID Numbers: | JZ-09-08, NHFC |
| Study First Received: | November 26, 2008 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New Hope Fertility Center:
|
IVF Research Study Infertility Sudy in vitro fertilization Mini IVF Conventional IVF |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013