IVF/ICSI Protocols in Poor Responders With Growth Hormone

October 19, 2015 updated by: Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

Which is the Best IVF/ICSI Protocol to be Used in Poor Responders Receiving Growth Hormone as an Adjuvant Treatment ? A Prospective Randomized Study

in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these patients.

Study Type

Interventional

Enrollment (Actual)

287

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
      • Giza, Cairo, Egypt, 12311
        • private IVF medical center

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:

ESHRE consensus 2011,At least two of the following three features must be present:

  • Advanced maternal age (≥40 years) or any other risk factor for POR;
  • A 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:

  • female patients with causes of infertility other than poor ovarian reserve
  • females suffering from congenital or acquired uterine anomalies
  • females with focal uterine lesions
  • females who had previous ovarian surgeries
  • females with history of previous exposure to radiotherapy , or chemotherapy
  • females refusing to get enrolled 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: The Long protocol
Patients in the group A received a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) which started on day 21 of preceding cycle at a dose of 0.1 mg/day. On the second day of menstruation HMG was started and this was associated with reduction of triptorelin to 0.05 mg/day. This reduced daily dose was administered until the day hCG was given. Growth hormone co-treatment 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)
Experimental: The Short protocol
The short agonist protocol was started on cycle day 1 with triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. Human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) were also administered starting from days 2 to 3 of cycle. The dose was adjusted for each patient according to the diameter of the follicles detected in their follow up ultrasound. 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)
Experimental: The Antagonist protocol
Gonadotrophins IM daily (HMG 75 IU, Merional, IBSA)was administrated from day 2 of the cycle. 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. The GnRH antagonist (Cetrotide) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC.
Drug: Growth hormone (Norditropin, Novo nordisk)
Experimental: The Microflare protocol
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of oocytes retrieved and number of fertilized oocytes
Time Frame: 2 years
Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.
2 years

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, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 8, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHC2013

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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