Protocols of IVF/ICSI in Poor Responders

Study Overview
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Brief Summary
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Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

Detailed Description
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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.

Official Title
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Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: Minimal stimulation protocol
* Drug: Microflare protocol
* Procedure: IVF/ICSI cycle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria: Advanced maternal age Previous poor ovarian response Abnormal tests of ovarian reserve (AFC < 5-7, AMH <0.5-1.1 ng/ml) Exclusion Criteria: Age > 43 years baseline FSH >15 mIU/ml Previous ovarian surgery Ovarian endometrioma Uterine anomaly or myoma Any medical disorder Any hormonal disorder eg. hyperprolactinemia BMI > 30 kg/m2 Severe male factor

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minimal Stimulation Group<br>Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist | Drug: Minimal stimulation protocol<br>* Letrozole, Recombinant FSH, GnRH antagonist<br>* Other names: Ovarian induction protocol;Procedure: IVF/ICSI cycle<br>* Involving ovum pickup and embryo transfer<br>|
| Active Comparator: Microflare Group<br>Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH | Drug: Microflare protocol<br>* OCP, GnRH agonist, Recombinant FSH<br>* Other names: Ovarian induction protocol;Procedure: IVF/ICSI cycle<br>* Involving ovum pickup and embryo transfer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |