Adjuvant Growth Therapy in in Vitro Fertilization

Ovo Clinic

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Adjuvant Growth Hormon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01715324

OVO-09-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 patients

Sex: Female

Ages: 35 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

Growth Hormon

Experimental group

Description:

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.

Treatment:

Drug: Adjuvant Growth Hormon

Control

No Intervention group

Description:

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).