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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02292953
Date of registration: 10/11/2014
Prospective Registration: No
Primary sponsor: Kasr El Aini Hospital
Public title: Variation in Serum Prolactin Levels During IntraCytoplasmic Sperm Injection
Scientific title: Variation in Serum Prolactin Levels in Response to Ovum Pickup for Patients Undergoing ICSI & it's Effect on Pregnancy Rate
Date of first enrolment: November 2014
Target sample size: 90
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT02292953
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Egypt
Contacts
Name:     Ahmed M Kamel, MD
Address: 
Telephone:
Email:
Affiliation:  Lecturer Of obstetrics & Gynecology
Name:     Ahmed M KameL, M.D
Address: 
Telephone: 01120022332
Email: dr.ahmed.m.kamel@gmail.com
Affiliation: 
Name:     Ahmed M Kamel, MD
Address: 
Telephone: 01120022332
Email: dr.ahmed.m.kamel@gmail.com
Affiliation: 
Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 43 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Infertility
Intervention(s)
Other: Serum Prolactin levels
Primary Outcome(s)
Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer [Time Frame: 6 months]
Secondary Outcome(s)
o Correlate serum prolactin levels (ng/mL) with Pregnancy rate. [Time Frame: 6 months]
Correlate serum prolactin levels (ng/mL) with number & quality of embryos [Time Frame: 6 months]
Secondary ID(s)
A13952014
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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