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Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles
The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal Stimulation Group | Active Comparator | Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist |
|
| Microflare Group | Active Comparator | Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal stimulation protocol | Drug | Letrozole, Recombinant FSH, GnRH antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | the number of oocytes collected from each participants in the two groups on the day of ovum pickup | 10 to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of MII oocytes retrieved | The mature oocytes colloected on the day of ovum pickup | 10 to 14 days |
| Number of fertilized oocytes | Number of oocytes fertilized |
| Measure | Description | Time Frame |
|---|---|---|
| Cancellation rate | Number of cycles not reaching ovum pickup | 10 to 14 days |
| Total dose of recombinant FSH | The mean total dose of recombinant FSH used in the cycle of treatment |
Inclusion Criteria:
1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarwat Ahwany, MD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini) | Cairo | 12311 | Egypt | |||
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
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| Microflare protocol | Drug | OCP, GnRH agonist, Recombinant FSH |
|
|
| IVF/ICSI cycle | Procedure | Involving ovum pickup and embryo transfer |
|
| 2 days |
| Number of embryos transferred | Number of embryos transferred in the induction cycle | Day 3 after ovum pickup |
| Number of embryos cryopreserved | Any surplus good quality embryos available for cryopreservation | Day 3 after ovum pickup |
| Chemical pregnancy rate | Positive pregnancy test | 14 days after embryo ransfer |
| Clinical pregnancy rate | Positive heart beat | 5 to 7 weeks after embryo transfer |
| Early miscarriage rate | loss of pregnancy before 12 weeks | 12 weeks |
| Ongoing pregnancy rate | pregnancy beyond 12 weeks | 12 weeks |
| Live birth rate | Delivery beyond 28 weeks | 28 to 40 weeks |
| 10 to 14 days |
| Cairo University |
| Cairo |
| Egypt |
| D000091662 | Genital Diseases |
| D007246 | Infertility |