Clinical trial NCT03105323: Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome
Official title: Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted at the IVF Unit at Ain Shams University Maternity Hospital.

Women will be recruited from the IVF Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Women with any type of subfertility undergoing IVF treatment.
2. Age between (20-40) years old
3. Body mass index between (20-40)
4. Selected embryo are of grade 1 and 2 quality.

Exclusion Criteria:

1. Age above 40 years old
2. BMI above 40
3. Bad quality embryo
4. Uterine anomalies or malformation that affect embryo transfer.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: a year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: