NCT01715324

Brief Summary

In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate aim of increasing the live birth rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_4

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

October 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 25, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

7 years

First QC Date

October 24, 2012

Last Update Submit

January 7, 2022

Conditions

Infertility

Keywords

In vitro fertilizationAntagonist protocolGrowth Hormone

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    To determine if the clinical pregnancy rate during the course of one treatment cycle in women receiving Growth Hormone daily in addition to gonadotropin-releasing hormone antagonist protocol is significantly higher than those receiving only gonadotropin-releasing hormone antagonist protocol (control group).

    7 weeks

Secondary Outcomes (13)

  • Total dose of gonadotropins

    7 weeks

  • Number of observed follicles

    7 weeks

  • Number of mature (Metaphase II) oocytes retrieved

    7 weeks

  • Oocyte morphology

    7 weeks

  • Fertilization rate

    7 weeks

  • +8 more secondary outcomes

Study Arms (2)

Growth Hormon

EXPERIMENTAL

The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication and will receive 2.5 mg of Adjuvant Growth Hormon (Saizen) daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering.

Drug: Adjuvant Growth Hormon

Control

NO INTERVENTION

The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication without Adjuvant Growth Hormon (Saizen).

Interventions

Adjuvant Growth HormonDRUG

The treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering

Also known as: Saizen
Growth Hormon

Eligibility Criteria

Age35 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women between the ages of 35 to 42
  • Primary or secondary infertility)
  • No previous treatment IVF cycle using the same proposed protocol
  • Negative pregnancy test at randomization (urine or blood)

You may not qualify if:

  • Contraindication to Saizen®
  • Simultaneous participation in another clinical trial
  • follicle stimulating hormone \> 12 IU/L and/or anti-mullerian hormone \< 0.5 pg/ml
  • Body mass index ≥ 35 kg/m2
  • Known risk of gestational diabetes
  • Administration of any investigational medication three months prior to study enrolment
  • Positive results of screening for either partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C
  • Not able to communicate in French or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Related Publications (2)

  • Mourad A, Jamal W, Hemmings R, Tadevosyan A, Phillips S, Kadoch IJ. Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial. Hum Reprod. 2025 Jan 1;40(1):77-84. doi: 10.1093/humrep/deae251.

    PMID: 39673334DERIVED

  • Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.

    PMID: 34808697DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jacques Kadoch, MD

    Clinique Ovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 26, 2012

Study Start

June 25, 2014

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

CA(1)