Clinical trial NCT01715324: Adjuvant Growth Therapy in in Vitro Fertilization
Official title: Adjuvant Growth Therapy in in Vitro Fertilization: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: In vitro fertilization
Antagonist protocol
Growth Hormone
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
Collaborators: name: EMD Serono
First posted: 2012-10-26
Enrollment: 288
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The addition of growth hormone, which is a biological hormone that can be synthetically produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth hormone has been shown, in animal and human studies, to be important in the recruitment of follicles.However, to date, only a limited number of clinical studies have been performed in order to assess whether the addition of growth hormone can improve the probability of pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total number of patients analysed in these studies was small it has not been possible to determine whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a woman is given growth hormone therapy as a supplement during her treatment.

This goal of this study is to determine the effectiveness of using growth hormone therapy as a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization protocol.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7 weeks
Secondary outcomes:
measure: Total dose of gonadotropins
timeFrame: 7 weeks
measure: Number of observed follicles
timeFrame: 7 weeks
measure: Number of mature (Metaphase II) oocytes retrieved
timeFrame: 7 weeks
measure: Oocyte morphology
timeFrame: 7 weeks
measure: Fertilization rate
timeFrame: 7 weeks
measure: Embryo morphology
timeFrame: 7 weeks
measure: Embryo cleavage rate
timeFrame: 7 weeks
measure: Number of embryos available
timeFrame: 7 weeks
measure: Number of supernumerary embryos available for cryopreservation
timeFrame: 7 weeks
measure: Implantation rate
timeFrame: 7 weeks
measure: Miscarriage rate
timeFrame: 40 weeks
measure: Live birth rate
timeFrame: 40 weeks
measure: Adverse side effects in women
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.