Infertility Clinical Trial
Official title:
Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial
Verified date | August 2009 |
Source | Royan Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics CommitteeIran: Ministry of Health |
Study type | Interventional |
This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.
Status | Completed |
Enrollment | 73 |
Est. completion date | December 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 37 Years to 43 Years |
Eligibility |
Inclusion Criteria: 1. Poor ovarian response to ovulation induction according to the ESHRE definition[20] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number < 5) 2. indication for ICSI treatment, second or third cycle 3. Age 37 to 43 years 4. Body mass index (BMI) = 30 kg/m2 5. The presence of two functional ovaries and no previous ovarian surgery 6. The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation 7. Basal (day 2 or 3) serum FSH levels =13 IU/L 8. Normal semen analysis 9. No history or signs of endometriosis 10. No untreated endocrinologic disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of mature oocytes | Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval | Up to 2 hours after oocyte retrieval | Yes |
Secondary | Number of retrieved oocytes | Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval | Up to 1 hour after oocyte retrieval | Yes |
Secondary | Number of generated embryos | Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval. | Up to 48-72 hours after oocyte retrieval | Yes |
Secondary | Quality of generated embryos | Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval. | Up to 48-72 hours after oocyte retrieval | Yes |
Secondary | Number of transferred embryos | Evaluation the number of transferred embryos on the time of embryo transfer. | on the time of embryo transfer | Yes |
Secondary | Quality of transferred embryos | Evaluation the quality of transferred embryos on the time of embryo transfer. | on the time of embryo transfer | Yes |
Secondary | implantation rate | Evaluation the implantation rate 4 weeks after embryo transfer. | 4 weeks after embryo transfer | Yes |
Secondary | chemical pregnancy rates | Evaluation the chemical pregnancy rates 2 weeks after embryo transfer. | 2 weeks after embryo transfer | Yes |
Secondary | clinical pregnancy rates | Evaluation the clinical pregnancy rates 4 weeks after embryo transfer. | 4 weeks after embryo transfer | Yes |
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