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Protocols of IVF/ICSI in Poor Responders

Primary Purpose

Infertility, Female

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Minimal stimulation protocol

Microflare protocol

IVF/ICSI cycle

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

30 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Minimal Stimulation Group

Microflare Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of oocytes retrieved

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

Secondary Outcome Measures

Number of MII oocytes retrieved

The mature oocytes colloected on the day of ovum pickup

Number of fertilized oocytes

Number of oocytes fertilized

Number of embryos transferred

Number of embryos transferred in the induction cycle

Number of embryos cryopreserved

Any surplus good quality embryos available for cryopreservation

Chemical pregnancy rate

Positive pregnancy test

Clinical pregnancy rate

Positive heart beat

Early miscarriage rate

loss of pregnancy before 12 weeks

Ongoing pregnancy rate

pregnancy beyond 12 weeks

Live birth rate

Delivery beyond 28 weeks

Full Information

NCT ID

NCT04356105

First Posted

April 18, 2020

Last Updated

November 15, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04356105

Brief Title

Protocols of IVF/ICSI in Poor Responders

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

September 30, 2021 (Actual)

Study Completion Date

October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Female

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minimal Stimulation Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Microflare Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Minimal stimulation protocol

Other Intervention Name(s)

Ovarian induction protocol

Intervention Description

Letrozole, Recombinant FSH, GnRH antagonist

Intervention Type

Drug

Intervention Name(s)

Microflare protocol

Other Intervention Name(s)

Ovarian induction protocol

Intervention Description

OCP, GnRH agonist, Recombinant FSH

Intervention Type

Procedure

Intervention Name(s)

IVF/ICSI cycle

Intervention Description

Involving ovum pickup and embryo transfer

Primary Outcome Measure Information:

Title

Number of oocytes retrieved

Description

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 Outcome Measure Information:

Title

Number of MII oocytes retrieved

Description

The mature oocytes colloected on the day of ovum pickup

Time Frame

10 to 14 days

Title

Number of fertilized oocytes

Description

Number of oocytes fertilized

Time Frame

2 days

Title

Number of embryos transferred

Description

Number of embryos transferred in the induction cycle

Time Frame

Day 3 after ovum pickup

Title

Number of embryos cryopreserved

Description

Any surplus good quality embryos available for cryopreservation

Time Frame

Day 3 after ovum pickup

Title

Chemical pregnancy rate

Description

Positive pregnancy test

Time Frame

14 days after embryo ransfer

Title

Clinical pregnancy rate

Description

Positive heart beat

Time Frame

5 to 7 weeks after embryo transfer

Title

Early miscarriage rate

Description

loss of pregnancy before 12 weeks

Time Frame

12 weeks

Title

Ongoing pregnancy rate

Description

pregnancy beyond 12 weeks

Time Frame

12 weeks

Title

Live birth rate

Description

Delivery beyond 28 weeks

Time Frame

28 to 40 weeks

Other Pre-specified Outcome Measures:

Title

Cancellation rate

Description

Number of cycles not reaching ovum pickup

Time Frame

10 to 14 days

Title

Total dose of recombinant FSH

Description

The mean total dose of recombinant FSH used in the cycle of treatment

Time Frame

10 to 14 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

43 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarwat Ahwany, MD

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Cairo

ZIP/Postal Code

12311

Country

Egypt

Facility Name

Cairo University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

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Protocols of IVF/ICSI in Poor Responders

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