Antagonist Protocol in Poor Responders

November 4, 2021 updated by: Yasmin Ahmed Bassiouny, Cairo University

Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial

The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 4

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
        • Kasr al 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

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females fulfilling the criteria of the ESHRE consensus 2011:
  • at least two of the following three features must be present:
  • dvanced maternal age (≥40 years) or any other risk factor for POR
  • previous POR (≤3 oocytes with a conventional stimulation protocol)
  • an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

Exclusion Criteria:

  • women who suffer from any other cause of infertility other than poor ovarian reserve
  • refusal of the patient to consent for using her data in the study.

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
Intervention / Treatment
Experimental: Antagonist and Growth hormone
HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
Drug: Growth Hormone
Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
Other Names:
  • Norditropin, Novo nordisk
No Intervention: Antagonist
HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth rate
Time Frame: Up to 9 months
Up to 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: Up to 5 weeks
Up to 5 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Chemical pregnancy rate
Time Frame: 5 weeks
5 weeks
Early miscarriage rate
Time Frame: Up to 12 weeks
Up to 12 weeks
Ongoing pregnancy rate
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Yomna A Bayoumi, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72014

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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