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Microflare Protocol in Poor Responders

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 responders, Poor ovarian response, IVF/ICSI, Microflare protocol, Growth hormone, Oral contraceptive pills

Eligibility Criteria

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

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.

Sites / Locations

  • Kasr el aini hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Microflare and growth hormone

Microflare protocol alone

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.

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rates

Secondary Outcome Measures

Full Information

First Posted
July 1, 2014
Last Updated
January 26, 2015
Sponsor
Woman's Health University Hospital, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT02185326
Brief Title
Microflare Protocol in Poor Responders
Official Title
Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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
The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders
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.

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 responders, Poor ovarian response, IVF/ICSI, Microflare protocol, Growth hormone, Oral contraceptive pills

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Microflare and growth hormone
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.
Arm Title
Microflare protocol alone
Arm Type
No Intervention
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
Intervention Type
Drug
Intervention Name(s)
Growth hormone (Norditropin, Novo nordisk)
Other Intervention Name(s)
Norditropin, Novo nordisk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical pregnancy rates
Time Frame
15 months

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: 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.
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
Kasr el aini hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
26381201
Citation
Bayoumi YA, Dakhly DM, Bassiouny YA, Hashish NM. Addition of growth hormone to the microflare stimulation protocol among women with poor ovarian response. Int J Gynaecol Obstet. 2015 Dec;131(3):305-8. doi: 10.1016/j.ijgo.2015.05.034. Epub 2015 Aug 23.
Results Reference
derived

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Microflare Protocol in Poor Responders

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