Adjuvant Growth Therapy in in Vitro Fertilization

NCT ID: NCT01715324

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-25
• Study Completion Date: 2021-08-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Growth Hormon

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.

Group Type: EXPERIMENTAL

Adjuvant Growth Hormon

Intervention Type: DRUG

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

Control

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adjuvant Growth Hormon

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

Intervention Type: DRUG

Other Intervention Names

Saizen

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: collaborator

Clinique Ovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Kadoch, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

Clinique Ovo

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39673334 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34808697 (View on PubMed)

Other Identifiers

OVO-09-03

Identifier Type: -

Identifier Source: org_study_id