Variation in Serum Prolactin Levels During IntraCytoplasmic Sperm Injection
NCT ID: NCT02292953
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2014-11-30
2015-06-30
Brief Summary
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Detailed Description
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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
.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Serum Prolactin levels
blood samples will be drawn from patients undergoing ICSI to analyse serum prolactin levels
Eligibility Criteria
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Inclusion Criteria
* Complaining of infertility 1ry or 2ry \& scheduled for ICSI.
Exclusion Criteria
* 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.
20 Years
43 Years
FEMALE
Yes
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Ahmed M.Kamel
Lecturer of Obstetric & Gynecology
Principal Investigators
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Ahmed M Kamel, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer Of obstetrics & Gynecology
Locations
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11562
Ḩadā’iq al Qubbah, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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A13952014
Identifier Type: -
Identifier Source: org_study_id