Poor Ovarian Reserve
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPolyethylene Glycol Recombinant Human Somatropin
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.
Sponsors
RenJi Hospital
The Second Hospital of Hebei Medical University
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 1)Married women between 35-40 years old; 2) serum AMH\< 1.2ng/ml, and basal FSH\<20IU/L during the screening period or within 6 months; 3) 18kg/m2≤BMI\<30kg/m2; 4) Previous ART cycles \<3.
Exclusion criteria
* 1）Gynecological diseases that affect pregnancy outcomes, such as submucous uterine myoma, intramural uterine myoma≥4cm, Ovarian cyst≥4cm, endometriosis, Uterine malformation, Tuberculosis of reproductive system; 2) Spontaneous abortion≥3 times; 3) Chromosomal abnormalities (except polymorphism) in one or both spouses; 4) Patients with well-defined and uncontrolled endocrine, metabolic, and adrenal diseases, such as diabetes, thyroid disease, Cushing's syndrome; 5) Patients with malignant tumors; 6) Previous use of somatropin products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastocyst formation rate | One year | the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100% |
| Live birth rate | One year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of retrieved oocytes | One year |
| Number of high-score embryos | One year |
| total amount of Gn used | One year |
Contacts
Primary ContactDaimin Wei
Outcome results
None listed