Variation in Serum Prolactin Levels During IntraCytoplasmic Sperm Injection

Variation in Serum Prolactin Levels in Response to Ovum Pickup for Patients Undergoing ICSI & it's Effect on Pregnancy Rate

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.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Other: Serum Prolactin levels

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Garden City, Cairo, Egypt, 11562
      • Recruiting
      • 11562
      • Contact: Ahmed M KameL, M.D; Phone Number: 01120022332; Email: dr.ahmed.m.kamel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 43 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Ninety normo-prolactinemic patients attending the Assisted reproduction unit in the Obstetrics and Gynecology Department-Faculty of Medicine -Cairo University, Scheduled for ICSI treatment cycle .Each participant will be subjected to infertility work up investigation in the form of semen analysis, hormonal profile (FSH, LH, TSH and prolactin).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Principal Investigator: Ahmed M Kamel, MD, Lecturer Of obstetrics & Gynecology

Publications and helpful links

General Publications

• Boyers SP, Lavy G, Russell JB, Polan ML, DeCherney AH. Serum prolactin response to embryo transfer during human in vitro fertilization and embryo transfer. J In Vitro Fert Embryo Transf. 1987 Oct;4(5):269-72. doi: 10.1007/BF01555202.
• Kamel A, Halim AA, Shehata M, AlFarra S, El-Faissal Y, Ramadan W, Hussein AM. Changes in serum prolactin level during intracytoplasmic sperm injection, and effect on clinical pregnancy rate: a prospective observational study. BMC Pregnancy Childbirth. 2018 May 9;18(1):141. doi: 10.1186/s12884-018-1783-4.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: ICSI; Embryo Transfer; Ovum Pickup
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: A13952014