Infertility Clinical Trial
Official title:
Assessing the Relation Between Hormone Receptors Gene Polymorphism and Ovarian Stimulation Response in In Vitro Fertilization (IVF) Program
Verified date | December 2015 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
The aim of this study is to assess the role of AMH in prediction of poor ovarian response as well as the relation between ESR2 (+1730G>A) (rs4986938), FSHR p.Thr307Ala (c.919A>G, rs6165) and FSHR p.Asn680Ser (c.2039A>G, rs6166) SNPs and the poor response in Egyptian women undergoing IVF procedure. Discovering the genetic variants associated with ovarian response is an important step towards individualized pharmacogenetic protocols of ovarian stimulation.
Status | Completed |
Enrollment | 216 |
Est. completion date | August 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Women at or under the age of 35 years. - Normal thyroid stimulating hormone and prolactin levels. - Normal ovulatory cycles (25-35 interval days), together with proven patent fallopian tubes at hysterosalpingography or laparoscopy done within six cycles preceding the ICSI cycle. - Presence of both ovaries with normal findings as assessed by trans-vaginal ultrasound and laparoscopy. - All male partners had a normal semen analysis according to WHO criteria (WHO, 2010), done within 6 months preceding the ICSI cycle Exclusion Criteria - Chronic medical disorders such as diabetes. - Previous inadequate response to ovulation induction. - Polycystic ovary syndrome. - Women who performed ovarian surgery and cases of endometriosis diagnosed by laparoscopy or suspected by ultrasound or CA-125 assay. - Abnormal pelvic pathology or congenital anomalies. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Laboratory analysis of basal follicle stimulating hormone level for each individual will be measured by enzyme-linked immunosorbent assay (ELISA) | Based on FSH level, the dose of HMG ( Merional) will be adjusted for each individual. | Done within 3 months preceeding the ICSI cycle | Yes |
Other | Laboratory analysis of anti-mullerian hormone level (AMH) will be measured by ELISA technique for each individual. | Based on AMH level, the dose of HMG (Merional) will be adjusted for each individual. | Done within 3 months preceeding the ICSI cycle. | Yes |
Primary | number of oocytes collected | when at least 3 follicles will reach 17 mm in diameter, ovulation will be triggered by a single intra-muscular injection of 10,000 IU of hCG [Choriomon® 5000 IU ampoules, IBSA institut]. 36 hours later, oocyte retrieval will be performed and will be guided by transvaginal ultrasound. | 3 weeks from of start of ICSI cycle | Yes |
Secondary | Detection of the single nucleotide polymorphisms ESR2(+1730G>A) (rs4986938), FSHR p.Thr307Ala (c.919A>G, rs6165) and FSHR p.Asn680Ser (c.2039A>G, rs6166) SNPs will be performed using the TaqMan system by real-time polymerase chain reaction (PCR) | By using PCR, we will indicate the genotype in each individual and determine the probability of the poor ovarian response. | Within 1 week | Yes |
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