InfertilityNCT02292953
Variation in Serum Prolactin Levels During IntraCytoplasmic Sperm Injection
An observational study of Infertility, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Serum Prolactin levels
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Age: adult female >20 years old.
- Complaining of infertility 1ry or 2ry \& scheduled for ICSI.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
11562
Ḩadā’iq al Qubbah, Cairo Governorate, 11562
Ahmed M KameL, M.D, 01120022332, dr.ahmed.m.kamel@gmail.com
About this study
Official title: 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.
Read the 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
.
- Conditions
- Infertility
- Being tested
- Serum Prolactin levels
- Keywords
- ICSI, Ovum Pickup, Embryo Transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Prolactin levelsOther
blood samples will be drawn from patients undergoing ICSI to analyse serum prolactin levels
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer
Measured: 6 months
Secondary outcomes (2)
o Correlate serum prolactin levels (ng/mL) with Pregnancy rate.
Measured: 6 months
Correlate serum prolactin levels (ng/mL) with number & quality of embryos
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M.Kamel, Kasr El Aini Hospital
- Investigators
- Ahmed M Kamel, MD, Principal investigator, Lecturer Of obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292953
- Sponsor's protocol ID
- A13952014
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 2961832Kamel 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.
PubMed 29739353
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Serum Prolactin Levels in Response to Ovum Pickup for Patients Undergoing ICSI & it's Effect on Pregnancy Rate
- ClinicalTrials.gov ID
- NCT02292953
- Acronym / sponsor ID
- A13952014
- Conditions
- Infertility
- Keywords
- ICSI, Ovum Pickup, Embryo Transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- Age: adult female >20 years old.
- Complaining of infertility 1ry or 2ry \& scheduled for ICSI.
Key exclusion criteria (9 listed)
- Hyperprolactinemia patients.
- Severe Male factor infertility
- Frozen embryo transfer cycles
- Uterine Anomalies.
- Repeated implantation failure in ICSI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Prolactin levelsblood samples will be drawn from patients undergoing ICSI to analyse serum prolactin levels | Other | – |
Primary outcome
Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer
Time frame: 6 months
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Background: PubMed 2961832Boyers 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.
- Derived from this study: PubMed 29739353Kamel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Kamel, MD principal investigator
Lecturer Of obstetrics & Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Kamel, MD (01120022332, dr.ahmed.m.kamel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Serum prolactin Levels (ng/mL) between ovum pickup & Embryo transfer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292953, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.