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Long Protocol and Growth Hormone in Poor Responders

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ClinicalTrials.gov Identifier: NCT02338206
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Growth hormone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial
Actual Study Start Date : March 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Infertility

Arm Intervention/treatment
Active Comparator: Long + Growth hormone
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.
Drug: Growth hormone
Other Name: Norditropin, Novo nordisk

No Intervention: Long protocol only
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.



Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 12 months ]
    Fresh, Frozen, Cumulative



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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT02338206


Locations
Egypt
Kasr el aini hospital
Cairo, Egypt, 12211
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Cairo University
Investigators
Principal Investigator: Dina M Dakhly, MD Cairo University

Responsible Party: Dina Mohamed Refaat Dakhly, lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT02338206     History of Changes
Other Study ID Numbers: LP112015
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt:
infertility

Additional relevant MeSH terms:
Infertility
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