Protocols of IVF/ICSI in Poor Responders

NCT ID: NCT04356105

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-10-31

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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minimal Stimulation Group

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

Group Type ACTIVE_COMPARATOR

Minimal stimulation protocol

Intervention Type DRUG

Letrozole, Recombinant FSH, GnRH antagonist

IVF/ICSI cycle

Intervention Type PROCEDURE

Involving ovum pickup and embryo transfer

Microflare Group

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

Group Type ACTIVE_COMPARATOR

Microflare protocol

Intervention Type DRUG

OCP, GnRH agonist, Recombinant FSH

IVF/ICSI cycle

Intervention Type PROCEDURE

Involving ovum pickup and embryo transfer

Interventions

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Minimal stimulation protocol

Letrozole, Recombinant FSH, GnRH antagonist

Intervention Type DRUG

Microflare protocol

OCP, GnRH agonist, Recombinant FSH

Intervention Type DRUG

IVF/ICSI cycle

Involving ovum pickup and embryo transfer

Intervention Type PROCEDURE

Other Intervention Names

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Ovarian induction protocol Ovarian induction protocol

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Ahmed Bassiouny

Assisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarwat Ahwany, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

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

Cairo, , Egypt

Site Status

Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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12020

Identifier Type: -

Identifier Source: org_study_id