Infertility, Female
Conditions
Brief summary
Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles
Detailed description
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.
Interventions
DRUGMinimal stimulation protocol
Letrozole, Recombinant FSH, GnRH antagonist
DRUGMicroflare protocol
OCP, GnRH agonist, Recombinant FSH
PROCEDUREIVF/ICSI cycle
Involving ovum pickup and embryo transfer
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria: 1. Advanced maternal age 2. Previous poor ovarian response 3. Abnormal tests of ovarian reserve (AFC \< 5-7, AMH \<0.5-1.1 ng/ml)
Exclusion criteria
1. Age \> 43 years 2. baseline FSH \>15 mIU/ml 3. Previous ovarian surgery 4. Ovarian endometrioma 5. Uterine anomaly or myoma 6. Any medical disorder 7. Any hormonal disorder eg. hyperprolactinemia 8. BMI \> 30 kg/m2 9. Severe male factor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes retrieved | 10 to 14 days | the number of oocytes collected from each participants in the two groups on the day of ovum pickup |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of MII oocytes retrieved | 10 to 14 days | The mature oocytes colloected on the day of ovum pickup |
| Number of fertilized oocytes | 2 days | Number of oocytes fertilized |
| Number of embryos transferred | Day 3 after ovum pickup | Number of embryos transferred in the induction cycle |
| Number of embryos cryopreserved | Day 3 after ovum pickup | Any surplus good quality embryos available for cryopreservation |
| Chemical pregnancy rate | 14 days after embryo ransfer | Positive pregnancy test |
| Ongoing pregnancy rate | 12 weeks | pregnancy beyond 12 weeks |
| Live birth rate | 28 to 40 weeks | Delivery beyond 28 weeks |
| Clinical pregnancy rate | 5 to 7 weeks after embryo transfer | Positive heart beat |
| Early miscarriage rate | 12 weeks | loss of pregnancy before 12 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cancellation rate | 10 to 14 days | Number of cycles not reaching ovum pickup |
| Total dose of recombinant FSH | 10 to 14 days | The mean total dose of recombinant FSH used in the cycle of treatment |
Countries
Egypt
Outcome results
None listed