Microflare Protocol in Poor Responders

January 26, 2015 updated by: Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?

The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

Study Type

Interventional

Enrollment (Actual)

145

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 El Aini Hospital

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:

(i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) 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: Microflare and growth hormone
the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. 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 (Norditropin, Novo nordisk)
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: Microflare protocol alone
the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rates
Time Frame: 15 months
15 months

Collaborators and Investigators

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

Sponsor

Woman's Health University Hospital, Egypt

Investigators

  • Principal Investigator: Dina M Dakhly, 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)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 6, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHE062013

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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