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Long Protocol and Growth Hormone in Poor Responders

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Growth hormone
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 Infertility focused on measuring infertility

Eligibility Criteria

20 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Poor responder females are those who posses two out of these three criteria:
  • Female age ≥40 years
  • Females who have at least one previous cancelled IVF cycle
  • POR according to AFC ≤ 5 or low AMH value.

Exclusion Criteria:

  • Females over 45 years
  • Females with FSH more than 20 IU/l
  • Females with previous ovarian surgery
  • Females suffering from causes of infertility other than poor ovarian response
  • Females refusing to be enrolled in the study

Sites / Locations

  • Kasr el aini hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Long + Growth hormone

Long protocol only

Arm Description

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration.

Outcomes

Primary Outcome Measures

Live birth rate
Fresh, Frozen, Cumulative

Secondary Outcome Measures

Full Information

First Posted
January 9, 2015
Last Updated
November 28, 2017
Sponsor
Woman's Health University Hospital, Egypt
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02338206
Brief Title
Long Protocol and Growth Hormone in Poor Responders
Official Title
Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long + Growth hormone
Arm Type
Active Comparator
Arm Description
Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.
Arm Title
Long protocol only
Arm Type
No Intervention
Arm Description
Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration.
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
Norditropin, Novo nordisk
Primary Outcome Measure Information:
Title
Live birth rate
Description
Fresh, Frozen, Cumulative
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Poor responder females are those who posses two out of these three criteria: Female age ≥40 years Females who have at least one previous cancelled IVF cycle POR according to AFC ≤ 5 or low AMH value. Exclusion Criteria: Females over 45 years Females with FSH more than 20 IU/l Females with previous ovarian surgery Females suffering from causes of infertility other than poor ovarian response Females refusing to be 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
Kasr el aini hospital
City
Cairo
ZIP/Postal Code
12211
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
29957401
Citation
Dakhly DMR, Bassiouny YA, Bayoumi YA, Hassan MA, Gouda HM, Hassan AA. The addition of growth hormone adjuvant therapy to the long down regulation protocol in poor responders undergoing in vitro fertilization: Randomized control trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:161-165. doi: 10.1016/j.ejogrb.2018.06.035. Epub 2018 Jun 22.
Results Reference
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Long Protocol and Growth Hormone in Poor Responders

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