Clinical trial NCT04588844: Effect of Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve.
Official title: Effect of Polyethylene Glycol Recombinant Human Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poor Ovarian Reserve
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: The Second Hospital of Hebei Medical University
First posted: 2020-10-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blastocyst formation rate
timeFrame: One year
measure: Live birth rate
timeFrame: One year
Secondary outcomes:
measure: Number of retrieved oocytes
timeFrame: One year
measure: Number of high-score embryos
timeFrame: One year
measure: total amount of Gn used
timeFrame: One year
measure: total days of Gn administration
timeFrame: One year
measure: clinical pregnancy rate
timeFrame: One year
measure: Ongoing pregnancy rate
timeFrame: One year
measure: E2 levels on triggering day
timeFrame: One year
measure: Endometrial thickness on triggering day
timeFrame: One year
Other outcomes:
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