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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
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Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. In this study, a prospective randomized control will be conducted to explore the effect of GH adjuvant therapy on clinical outcome of in vitro fertilization.
Eligible subjects will be randomly assigned into either the study groups (receive somatropin co-treatment) or the control group (without sopmatropin treatment). Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) for approximately 6 weeks, i.e. from the beginning of preceding menstruation cycle until the day of ovum pickup. Both groups will receive a similar common protocol for ovarian stimulation. In vitro fertilization with or without intracytoplasmic sperm injection will be performed according to semen parameters. All embryos will undergo culture for blastocyst and the obtained blastocysts will be vitrified for deferred frozen embryo transfer. The Blastocyst formation rate will be the primary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth Hormone group | Experimental | Growth Hormone pretreatment for 6 weeks before ovarian stimulation |
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| Control group | No Intervention | No pretreatment before ovarian stimulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol Recombinant Human Somatropin | Drug | Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) from the beginning of preceding menstruation cycle until the day of ovum pickup. |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst formation rate | the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100% | One year |
| Live birth rate | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of retrieved oocytes | One year | |
| Number of high-score embryos | One year | |
| total amount of Gn used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daimin Wei | Contact | 0531-85652419 | sdweidaimin@163.com |
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The study protocol and statistical analysis plan will be available online with publication. Data collected for the study, including specified data set and a data dictionary defining each field in the set, will be made available to others with publication.
After publication and for 1 year
Investigators can request data sharing by contacting the email of the corresponding author. Our publication committee established for this trial will review and approve the request.
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| One year |
| total days of Gn administration | One year |
| clinical pregnancy rate | One year |
| Ongoing pregnancy rate | One year |
| E2 levels on triggering day | One year |
| Endometrial thickness on triggering day | One year |