Variation in Serum Prolactin Levels During IntraCytoplasmic Sperm Injection

• Conditions: Infertility

• Registration Number: NCT02292953
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

The purpose of the study is to determine whether or not stressful conditions such as ovum pick and awaiting Embryo Transfer is associated with significant increase in serum Prolactin (PRL) concentration in some normo-prolactinemic patients undergoing intracytoplasmatic sperm injection (ICSI) \& possible effect on implantation \& pregnancy rate.

Detailed Description

Methodology in details:

After applying inclusion and exclusion criteria to infertile patients scheduled for start of ICSI cycle at kasr alainy assisted reproduction unit, and taking the patient's informed consent for all blood samples that will be drawn from her.

The baseline serum prolactin level is recorded and the first blood sample is scheduled to be taken in operating room just before induction of anesthesia for ovum pickup. A Second blood sample will be taken two hours after aspiration of the last follicle in recovery room post-operatively.

A third final blood sample will be taken before Embryo transfer .The blood samples will be sent immediately to central laboratory in Kasr Alainy Cairo University Hospital after being obtained on every occasion, and Serum prolactin will be analyzed by immunoassay in each time.

Descriptive data such as age, type of infertility \& cause will be recorded. Also result of every serum prolactin level will be recorded as well as type of protocol used for ovulation induction, number of oocytes retrieved at ovum pick up, embryo grading and day of transfer.

Serum beta human chorionic gonadotropin (B-hCG) will be drawn from the patient 2 weeks after the date of embryo transfer to determine pregnancy and recorded.

Statistical analysis will be done for the laboratory results, All statistical calculations were performed using the computer program SPSS (Statistical Package for the Social Science; SPSS Inc.) version 15 for Microsoft Windows

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Study Timeline

• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-17
• Last Update Submitted: 2014-11-17
• Study First Posted: 2014-11-18
• Last Update Posted: 2014-11-18
• Primary Completion: 2015-05
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Age: adult female >20 years old.
• Complaining of infertility 1ry or 2ry & scheduled for ICSI.

Exclusion Criteria

• Hyperprolactinemia patients.
• Severe Male factor infertility
• Frozen embryo transfer cycles
• Uterine Anomalies.
• Repeated implantation failure in ICSI.
• Any contraindications for Pregnancy as(serious uncontrolled medical diseases such as Diabetes, heart disease, hypertension), mental illnesses, ovarian tumors,cancer of any location and Acute inflammatory disease).
• On medication that is known to alter prolactin levels e.g antipsychotics, Atypical agents and risperidone
• Thyroid dysfunction.
• Medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and hypothyroidism.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer	6 months

Secondary Outcome Measures

Name	Time	Method
o Correlate serum prolactin levels (ng/mL) with Pregnancy rate.	6 months
Correlate serum prolactin levels (ng/mL) with number & quality of embryos	6 months

Trial Locations

Locations (1)

11562; 🇪🇬 Garden City, Cairo, Egypt