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IVF/ICSI Protocols in Poor Responders With Growth Hormone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897324
First Posted: July 11, 2013
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
  Purpose
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.

Condition Intervention Phase
Female Infertility Due to Diminished Ovarian Reserve Drug: Growth hormone (Norditropin, Novo nordisk) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Which is the Best IVF/ICSI Protocol to be Used in Poor Responders Receiving Growth Hormone as an Adjuvant Treatment ? A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • 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.


Enrollment: 287
Study Start Date: July 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897324


Locations
Egypt
private IVF medical center
Giza, Cairo, Egypt, 12311
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Dina M Dakhly, MD Cairo University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dina Mohamed Refaat Dakhly, lecturer of obstetrics and gynecology, cairo university, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01897324     History of Changes
Other Study ID Numbers: WHC2013
First Submitted: July 2, 2013
First Posted: July 11, 2013
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt:
Poor Ovarian Response
Poor Responders
IVF/ICSI
Growth Hormone

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Hormones
Menotropins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents


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