Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EMD Serono | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Growth Hormon | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of gonadotropins | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Number of observed follicles |
Not provided
Inclusion Criteria:
Women between the ages of 35 to 42
Primary or secondary infertility)
Negative pregnancy test at randomization (urine or blood)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacques Kadoch, MD | Clinique Ovo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Ovo | Montreal | Quebec | H4P 2S4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39673334 | Derived | 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. | |
| 34808697 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
| 7 weeks |
| Number of mature (Metaphase II) oocytes retrieved | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Oocyte morphology | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Fertilization rate | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Embryo morphology | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Embryo cleavage rate | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Number of embryos available | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Number of supernumerary embryos available for cryopreservation | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Implantation rate | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| Miscarriage rate | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 40 weeks |
| Live birth rate | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 40 weeks |
| Adverse side effects in women | To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group. | 7 weeks |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |