NCT02292953

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

November 10, 2014

Last Update Submit

November 17, 2014

Conditions

Infertility

Keywords

ICSIOvum PickupEmbryo Transfer

Outcome Measures

Primary Outcomes (1)

  • Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer

    6 months

Secondary Outcomes (2)

  • 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

Interventions

Serum Prolactin levelsOTHER

blood samples will be drawn from patients undergoing ICSI to analyse serum prolactin levels

Eligibility Criteria

Age20 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

11562

Ḩadā’iq al Qubbah, Cairo Governorate, 11562, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 2961832BACKGROUND

  • 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.

    PMID: 29739353DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ahmed M Kamel, MD

    Lecturer Of obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Kamel, MD

CONTACT

01120022332dr.ahmed.m.kamel@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetric & Gynecology

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 18, 2014

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

EG(1)