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IVF/ICSI Protocols in Poor Responders With Growth Hormone

Primary Purpose

Female Infertility Due to Diminished Ovarian Reserve

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Growth hormone (Norditropin, Novo nordisk)
Sponsored by
Woman's Health University Hospital, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Infertility Due to Diminished Ovarian Reserve focused on measuring Poor Ovarian Response, Poor Responders, IVF/ICSI, Growth Hormone

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • private IVF medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

The Long protocol

The Short protocol

The Antagonist protocol

The Microflare protocol

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Numbers of oocytes retrieved and number of fertilized oocytes
Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2013
Last Updated
October 19, 2015
Sponsor
Woman's Health University Hospital, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT01897324
Brief Title
IVF/ICSI Protocols in Poor Responders With Growth Hormone
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility Due to Diminished Ovarian Reserve
Keywords
Poor Ovarian Response, Poor Responders, IVF/ICSI, Growth Hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Long protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
The Short protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
The Antagonist protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
The Microflare protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Growth hormone (Norditropin, Novo nordisk)
Primary Outcome Measure Information:
Title
Numbers of oocytes retrieved and number of fertilized oocytes
Description
Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina M Dakhly, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
private IVF medical center
City
Giza
State/Province
Cairo
ZIP/Postal Code
12311
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
26416521
Citation
Dakhly DM, Bayoumi YA, Gad Allah SH. Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial. Gynecol Endocrinol. 2016;32(2):116-9. doi: 10.3109/09513590.2015.1092136. Epub 2015 Sep 29.
Results Reference
derived

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IVF/ICSI Protocols in Poor Responders With Growth Hormone

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