Protocols of IVF/ICSI in Poor Responders

Cairo University132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Infertility, Female

Interventions

Minimal stimulation protocolDRUG

Letrozole, Recombinant FSH, GnRH antagonist

Microflare protocolDRUG

OCP, GnRH agonist, Recombinant FSH

IVF/ICSI cyclePROCEDURE

Involving ovum pickup and embryo transfer

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 43 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Cairo, Egypt

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Number of oocytes retrieved

the number of oocytes collected from each participants in the two groups on the day of ovum pickup

Time frame: 10 to 14 days

Secondary Outcomes

Number of MII oocytes retrieved

The mature oocytes colloected on the day of ovum pickup

Time frame: 10 to 14 days

Number of fertilized oocytes

Number of oocytes fertilized

Time frame: 2 days

Number of embryos transferred

Number of embryos transferred in the induction cycle

Time frame: Day 3 after ovum pickup

Number of embryos cryopreserved

Any surplus good quality embryos available for cryopreservation

Time frame: Day 3 after ovum pickup

Chemical pregnancy rate

Positive pregnancy test

Time frame: 14 days after embryo ransfer

Clinical pregnancy rate

Positive heart beat

Time frame: 5 to 7 weeks after embryo transfer

Early miscarriage rate

loss of pregnancy before 12 weeks

Time frame: 12 weeks

Ongoing pregnancy rate

pregnancy beyond 12 weeks

Data from ClinicalTrials.gov

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