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UnknownNCT03105323

Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Ain Shams Maternity Hospital · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

Summary

This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital. Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study The study will assess Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm Injection outcome.

Detailed description

Blood samples were collected on the day of final oocyte maturation, and serum Progesterone levels were measured using a chemiluminescent immunoassay for quantitative determination of the hormone . The P/F ratio was calculated according to the equation (P(ng/mL)/number of follicles) and was defined by the measurements obtained on the day of final oocyte maturation. All ultrasounds were performed at our In vitro fertilization center, and we included the number of follicles ≥14mm on the day of final oocyte maturation in the ratio calculation Oocytes were retrieved 36 hours after injection and were subsequently fertilized by In vitro fertilization or Intra cytoplasmic sperm injection. On day 2 - 5, all embryos were evaluated for cell number and morphology. Each embryo transferred was evaluated for blastomere size and fragmentation. Embryos were graded as follows. Those with equal blastomere size and no fragmentation were considered Grade 1; those with blastomeres of equal size with slight fragmentation (\<20 %) were Grade 2;those with blastomeres of unequal size but no fragmentation were Grade 3; those with blastomeres of equal or unequal size and moderate fragmentation (20 %-50 %) were Grade 4; and those with unrecognizable blastomeres and severe fragmentation (\>50 %) were Grade 5. The embryos were transferred on postretrieval day (2 - 5). Pregnancy was defined by Human chorionic gonadotropin titers within 11 days following Embryo transfer. Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.

Conditions

Timeline

Start date
2017-05-01
Primary completion
2018-03-31
Completion
2018-03-31
First posted
2017-04-07
Last updated
2017-04-07

Source: ClinicalTrials.gov record NCT03105323. Inclusion in this directory is not an endorsement.