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| NHFC |
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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A - Mini IVF | Active Comparator | 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. |
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| Arm B - Conventional IVF | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in vitro fertilization (IVF/ICSI) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome parameter: Live birth | 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome parameters: Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Multiple pregnancy rate, Miscarriage rate, Fertilization rate, Number of oocytes, Number of embryos | 4 Years |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J Zhang, MD, MSc, PhD | New Hope Fertility Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Hope Fertility Center | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28620528 | Derived | Zhang JJ, Yang M, Merhi Z. Efficiency of metaphase II oocytes following minimal/mild ovarian stimulation in vitro fertilization. Fertil Res Pract. 2016 Sep 1;2:2. doi: 10.1186/s40738-016-0025-6. eCollection 2016. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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