Protocols of IVF/ICSI in Poor Responders

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Infertility, Female

Treatments: Drug: Minimal stimulation protocol; Procedure: IVF/ICSI cycle; Drug: Microflare protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04356105

12020

Details and patient eligibility

About

Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

Full 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.

Enrollment: 132 patients

Sex: Female

Ages: 30 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Minimal Stimulation Group

Active Comparator group

Description:

Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist

Treatment:

Procedure: IVF/ICSI cycle

Drug: Minimal stimulation protocol

Microflare Group

Active Comparator group

Description:

Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH

Treatment:

Drug: Microflare protocol

Procedure: IVF/ICSI cycle