Protocols of IVF/ICSI in Poor Responders

November 15, 2021 updated by: Yasmin Ahmed Bassiouny, Cairo University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University
      • Cairo, Egypt, 12311
        • IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Minimal Stimulation Group
Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist
Drug: Minimal stimulation protocol
Letrozole, Recombinant FSH, GnRH antagonist
Other Names:
  • Ovarian induction protocol
Procedure: IVF/ICSI cycle
Involving ovum pickup and embryo transfer
Active Comparator: Microflare Group
Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH
Procedure: IVF/ICSI cycle
Involving ovum pickup and embryo transfer
Drug: Microflare protocol
OCP, GnRH agonist, Recombinant FSH
Other Names:
  • Ovarian induction protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved
Time Frame: 10 to 14 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of MII oocytes retrieved
Time Frame: 10 to 14 days
The mature oocytes colloected on the day of ovum pickup
10 to 14 days
Number of fertilized oocytes
Time Frame: 2 days
Number of oocytes fertilized
2 days
Number of embryos transferred
Time Frame: Day 3 after ovum pickup
Number of embryos transferred in the induction cycle
Day 3 after ovum pickup
Number of embryos cryopreserved
Time Frame: Day 3 after ovum pickup
Any surplus good quality embryos available for cryopreservation
Day 3 after ovum pickup
Chemical pregnancy rate
Time Frame: 14 days after embryo ransfer
Positive pregnancy test
14 days after embryo ransfer
Clinical pregnancy rate
Time Frame: 5 to 7 weeks after embryo transfer
Positive heart beat
5 to 7 weeks after embryo transfer
Early miscarriage rate
Time Frame: 12 weeks
loss of pregnancy before 12 weeks
12 weeks
Ongoing pregnancy rate
Time Frame: 12 weeks
pregnancy beyond 12 weeks
12 weeks
Live birth rate
Time Frame: 28 to 40 weeks
Delivery beyond 28 weeks
28 to 40 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cancellation rate
Time Frame: 10 to 14 days
Number of cycles not reaching ovum pickup
10 to 14 days
Total dose of recombinant FSH
Time Frame: 10 to 14 days
The mean total dose of recombinant FSH used in the cycle of treatment
10 to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sarwat Ahwany, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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