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

• Conditions: Infertility, Female

• Registration Number: NCT03105323
• Lead Sponsor: Ain Shams Maternity Hospital

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.

Study Timeline

• Study First Submitted: 2017-03-24
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Study First Posted: 2017-04-07
• Last Update Posted: 2017-04-07
• Study Start: 2017-05-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	a year	rate of incidence of pregnancy after Intracytoplasmic Sperm Injection