NCT02338206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

January 9, 2015

Last Update Submit

November 28, 2017

Conditions

Infertility

Keywords

infertility

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    Fresh, Frozen, Cumulative

    12 months

Study Arms (2)

Long + Growth hormone

ACTIVE COMPARATOR

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

Long protocol only

NO INTERVENTION

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.

Interventions

Growth hormoneDRUG
Also known as: Norditropin, Novo nordisk
Long + Growth hormone

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, 12211, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 29957401DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Growth HormoneHuman Growth Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Dina M Dakhly, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 14, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 15, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

EG(1)