IVF/ICSI Protocols in Poor Responders With Growth Hormone

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Woman's Health University Hospital, Egypt
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01897324
First received: July 2, 2013
Last updated: March 4, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • Numbers of oocytes retrieved and number of fertilized oocytes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.


Estimated Enrollment: 287
Study Start Date: September 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897324

Contacts
Contact: Dina M Dakhly, MD 01003498919 ext 002 dinadakhly@gmail.com

Locations
Egypt
private IVF medical center Recruiting
Giza, Cairo, Egypt, 12311
Contact: Dina M Dakhly, MD    01003498919 ext 002    dinadakhly@gmail.com   
Principal Investigator: Dina M Dakhly, MD         
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Dina M Dakhly, MD Cairo University
  More Information

No publications provided

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
Study First Received: July 2, 2013
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014