Infertility, Female Clinical Trial
Official title:
Efficacy of Growth Hormone Supplementation With Gonadotrophins in IVF/ICSI for Poor Responders; a Randomized Controlled Trial
Verified date | June 2019 |
Source | ClinAmygate |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to assess the effectiveness of adjuvant growth hormone injection during controlled ovarian stimulation, in poor responder women undergoing intracytoplasmic sperm injection (ICSI) procedures.
Status | Completed |
Enrollment | 156 |
Est. completion date | June 5, 2019 |
Est. primary completion date | May 5, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 38 Years |
Eligibility |
Inclusion Criteria: - Age: 25 to 38 years old. - IVF previous poor responders: at least two failed cycles with < five oocytes or abnormal ORT e.g. antimullerian hormone < 1 - Patients with unexplained infertility. - Normal follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin and ovarian ultrasound. - Normal pelvic ultrasound including 3D ultrasound of the uterus with no detected hydrosalpinx. Exclusion Criteria: - Refusal to participate in the study - Patients with known medical disease (e.g. severe hypertension or hepatic disease). - Altered karyotype in one or both partners. - History of chronic, autoimmune or metabolic diseases - Presence of endocrinopathies. |
Country | Name | City | State |
---|---|---|---|
Egypt | Al Azhar University Hospitals (Kasr Al-Aini) | Cairo |
Lead Sponsor | Collaborator |
---|---|
ClinAmygate | National Research Center, Egypt |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate | The main outcome is clinical pregnancy per allocated woman, defined as the presence of at least one fetus with heart beat. | 3 weeks | |
Secondary | E2 levels | Human Chorionic Gonadotropin (HCG) is given to induce triggering of ovulation then ovum pick up is scheduled 36 hour after the injection. | Day 1 of COS, the same day of Human Chorionic Gonadotropin (HCG) injection | |
Secondary | Number of oocytes collected | Transvaginal ultrasound will be done starting from day 6 of COS for assessment of follicular development and assessment of endometrial thickness, serial E2 measurement will be scheduled to start on day 6 of COS repeating every other day | Day 6 of COS | |
Secondary | Metaphase I (MI) and Metaphase II (MII) oocyte number | Transvaginal ultrasound will be done starting from day 6 of COS for assessment of follicular development and assessment of endometrial thickness, serial E2 measurement will be scheduled to start on day 6 of COS repeating every other day | Day 6 of COS | |
Secondary | Number of Pronucleus | Transvaginal ultrasound will be done starting from day 6 of COS for assessment of follicular development and assessment of endometrial thickness, serial E2 measurement will be scheduled to start on day 6 of COS repeating every other day | Day 6 of COS | |
Secondary | Multiple pregnancy | Multiple pregnancy | 6 weeks from last period |
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