Skip to content

The clinical outcomes after ICSI in couple with diminished ovarian reserve and high Sperm DNA fragmentation by ovarian co-stimulation with growth hormone: a prospective, randomized, parallel controlled study

The clinical outcomes after ICSI in couple with diminished ovarian reserve and high Sperm DNA fragmentation by ovarian co-stimulation with growth hormone: a prospective, randomized, parallel controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17012469
Enrollment
Unknown
Registered
2017-08-24
Start date
2017-10-01
Completion date
Unknown
Last updated
2017-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diminished ovarian reserve

Interventions

GH group:GH 0.5ml (4.5IU) subcutaneous injection before bedtime on alternate days
Blank control group:none

Sponsors

Reproductive Medicine Center of the First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
38 Years to 43 Years

Inclusion criteria

Inclusion criteria: 1) Women were 38~43 years old; 2) Woman must meet at least 2 of the 3 items: Basal FSH2~20 IU/l, Antral follicle count=7, AMH=1.1ng/ml; 3) SCD method was used to detect semen samples at least 2 times, and the sperm fragmentation index was 27.3%; 4) Agreed to sign informed consent.

Exclusion criteria

Exclusion criteria: 1) The couple with chromosome abnormalities; 2) Women with clinically significant systemic diseases such as hypertension, tumors such as pituitary adenoma, craniopharyngioma, female reproductive system tumors, malignant tumors such as endometrial cancer, endocrine or metabolic abnormalities such as hyperprolactinemia, Cushing syndrome, glucose intolerance, diabetes, thyroid disease, growth hormone deficiency, autoimmune the disease, such as systemic lupus erythematosus, Sjogren syndrome, Hashimoto's thyroiditis, multiple sclerosis, rheumatoid arthritis, autoimmune hemolytic anemia and polycystic ovary disease; 3) BMI>25(kg/m2); 4) Women with abnormal endometrial hyperplasia, uterine fibroids more than 5cm or any size but compression of the endometrium, adenomyosis, uterine malformation, severe uterine adhesions and hydrosalpinx > 2cm; 5) Women with history of habitual abortion; 6) Women with preoperative examination show more than 25% normal range, or tumor markers CA125, CEA, CA199 and AFP increase; 7) Women with known severe mental illness or don't understand the clinical testing purposes, methods, and do not comply with the study procedures; 8) Women who abuse drugs; 9) Women with growth hormone allergy history; 10) Women with her spouses sperm concentration was less than 1 * 10^5/ml; 11) Womens spouse suffered from reproductive system tumors or tuberculosis; 12) Women registration to participate in this study and later took part in any other clinical trial or during this study randomly selected 3 months ago had participated in additional clinical studies; 13) Smoking more than 10 cigarettes per day; 14) Women had other cases that the researchers consider unsuitable for the study, such as adverse reactions related to study medication, blood glucose fluctuation is too large, a local injection site reactions (pain, numbness, swelling and other symptoms) and fluid retention (peripheral edema, joint pain or muscle pain).

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate of frozen-thawed embryo transfer (FET) treatment cycles;

Secondary

MeasureTime frame
Cumulative pregnancy rate;Gonadotropins dosage;Gonadotropins usage duration;The number of follicles =12mm on the day of hCG administration;E2 level on the day of hCG administration, cycle cancellation rate;Oocytes (MII) retrieved rate;Fertilization rate;High quality embryo rate;Number of embryos for frozen;Endometrial thickness on the day of FET (mm);Implantation rate;Biochemical pregnancy rate;Early miscarriage rate;Ectopic pregnancy rate;Ongoing pregnancy rate;Live birth rate;Take home baby rate;

Countries

China

Contacts

Public ContactXuefeng Huang
xuefhuang@126.com+86 13600674186

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026