Infertility
Conditions
Brief summary
This study was a prospective randomized controlled trial. Patients aged \<35 years with decreased clinical reserve function (AFC\<5, Follicle stimulating hormone \> 10miu/ml, Anti-mullerian hormone \< 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/ICSI.
Interventions
DRUGGrowth hormone
3 months of growth hormone treatment (2 units daily)
Sponsors
Nanjing University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 34 Years
Healthy volunteers
No
Inclusion criteria
1. Age \< 35 years; 2. AFC≤5 3. Follicle stimulating hormone \> 10miu/ml; 4. Anti-mullerian hormone \< 1.1μg/L (2 out of 2-4 items can be met)
Exclusion criteria
1. Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa; 2. Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation; 3. Diabetes mellitus, insulin resistance; 4. chromosomal karyotype abnormality in either spouse; 5. Any pregnancy or contraindications of assisted reproductive technology;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of embryos | 4 months | When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of oocytes retrieved | 4 months | When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of oocytes retrieved was recorded. |
| Clinical pregnancy rate | 5-8months | Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-Human chorionic gonadotropin 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer |
Countries
China
Contacts
Primary ContactQingqing Shi, PHD
Outcome results
None listed